New Drug/Vaccine Approval

Journavx™ (suzetrigine) Tablets - formerly VX-548 – New Drug Approval – January 30, 2025 - The U.S. Food and Drug Administration approved Journavx™ (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx™ reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Journavx™ is the first drug to be approved in this new class of pain management medicines. <Read More> 

Symbravo™ (meloxicam and rizatriptan) Tablets - formerly AXS-07 – New Drug Approval – January 30, 2025 - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) has approved Symbravo® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo® represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. <Read More> 

Grafapex™ (treosulfan) Lyophilized Powder for Injection – New Drug Approval – January 22, 2025 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for Grafapex™ (treosulfan) for injection with the US Food and Drug Administration and, in addition, to announce preliminary estimates of the company's operating and financial results for the company's third fiscal quarter ended December 31, 2024 (which remain subject to completion of Medexus's financial closing procedures). All dollar amounts in this news release are in US dollars unless specified otherwise. <Read More> 

Datroway® (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection – New Drug Approval – January 17, 2025 - The Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. <Read More> 

Opdivo® Qvantig™ (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection – New Drug Approval – December 27, 2024 - The Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo® Qvantig™, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo®, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. <Read More> 

Alhemo® (concizumab-mtci) Injection – New Drug Approval – December 20, 2024 - The U.S. Food and Drug Administration has approved Alhemo® (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Alhemo® is injected subcutaneously (under the skin) daily. <Read More> 

Alyftrek™ (deutivacaftor, tezacaftor and vanzacaftor) – New Drug Approval – December 20, 2024 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to Alyftrek™. <Read More> 

Tryngolza™ (olezarsen) Injection – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration has approved Tryngolza™ (olezarsen), used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). This is a first-in-class approval, meaning Tryngolza™ uses a new mechanism of action, or works differently in the body, than other therapies currently used to treat FCS. Tryngolza™ is injected subcutaneously (under the skin) once per month. <Read More> 

Symvess™ (acellular tissue engineered vessel-tyod) for Surgical Vascular Implantation – New Drug Approval – December 19, 2024 - The U.S. Food and Drug Administration approved Symvess™, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible. Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting. <Read More> 

Ryoncil® (remestemcel-L-rknd) Cell Suspension for Intravenous Infusion – New Drug Approval – December 18, 2024 - The FDA approved remestemcel-L-rknd (brand name Ryoncil®), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older. Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy. <Read More> 

Ensacove™ (ensartinib) Capsules – New Drug Approval – December 18, 2024 - The Food and Drug Administration approved ensartinib (Ensacove™, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. <Read More> 

Crenessity™ (crinecerfont) Capsules and Oral Solution – New Drug Approval – December 13, 2024 - The U.S. Food and Drug Administration approved Crenessity™ (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH). <Read More>  

Unloxcyt™ (cosibelimab-ipdl) Injection – New Drug Approval – December 13, 2024 - The Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt™, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. <Read More> 

Bizengri® (zenocutuzumab-zbco) Injection – New Drug Approval – December 4, 2024 - The Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri®, Merus N.V.) for adults with the following:  1) advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or 2) advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion. <Read More> 

Attruby™ (acoramidis) Tablets – New Drug Approval – November 25, 2024 - The U.S. Food and Drug Administration has approved Attruby™ (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. ATTR-CM is a rare and serious disease that affects the heart muscle. In patients with ATTR-CM, there is a build-up of protein deposits in the heart, causing the walls of the heart to become stiff, and making the left ventricle unable to properly relax and fill with blood (called cardiomyopathy). As the condition progresses, the heart can become unable to pump blood out adequately, causing heart failure. <Read More> 

Imkeldi™ (imatinib mesylate) Oral Solution – New Drug Approval – November 22, 2024 - Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has approved Imkeldi™ (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. “We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, chief executive officer of Shorla. “Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.” <Read More> 

Rapiblyk™ (landiolol) Lyophilized Powder for Injection – New Drug Approval – November 22, 2024 - AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk™ (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that Rapiblyk™ (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time. <Read More> 

New Indication/Dosage/Formulation Approval

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – January 28, 2025 – AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. <Read More> 

Ozempic® (semaglutide) Injection – New Label Expansion – January 28, 2025 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. <Read More> 

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – January 27, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing. Leqembi® is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. <Read More> 

Spravato® (esketamine) Nasal Spray – New Label Expansion – January 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for Spravato® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. <Read More> 

Lumakras® (sotorasib) Tablets – New Label Expansion – January 16, 2025 – The Food and Drug Administration approved sotorasib (Lumakras®, Amgen Inc.) with panitumumab (Vectibix®, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. <Read More> 

Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – January 16, 2025 – AstraZeneca’s Calquence® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress. <Read More> 

Omvoh® (mirikizumab-mrkz) Injection – New Label Expansion – January 15, 2025 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. Omvoh® is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. <Read More> 

Niktimvo™ (axatilimab-csfr) Injection – New Label Expansion – January 15, 2025 – Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The Companies expect product to be available for order in the U.S. in early February. Niktimvo™ is approved for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). Niktimvo™ is the first and only FDA-approved prescription treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis. <Read More>

Tevimbra® (tislelizumab-jsgr) Injection – New Label Expansion – December 26, 2024 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1). <Read More> 

Zepbound® (tirzepatide) Injection – New Label Expansion – December 20, 2024 – Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound® may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity. <Read More>  

Braftovi® (encorafenib) Capsules – New Label Expansion – December 20, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. <Read More> 

Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules – New Label Expansion – December 20, 2024 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta® based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508del CFTR mutations have been added to the Trikafta® label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time. <Read More> 

Imcivree® (setmelanotide) Injection – New Label Expansion – December 20, 2024 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Imcivree® (setmelanotide) to include children as young as 2 years old. Imcivree® is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. <Read More> 

Gemtesa® (vibegron) Tablets – New Label Expansion – December 18, 2024 – Sumitomo Pharma America, Inc. (SMPA) announced that the U.S. Food and Drug Administration (FDA) has approved Gemtesa® (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks Gemtesa® as the first and only β3 agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S. <Read More> 

Nemluvio® (nemolizumab) for Injection – New Label Expansion – December 13, 2024 – Galderma announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio® for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024. <Read More> 

Vtama® (tapinarof) Cream – New Label Expansion – December 12, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, announced that the U.S. Food and Drug Administration (FDA) has approved Vtama® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older. Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025. <Read More> 

Imfinzi® (durvalumab) Injection – New Label Expansion – December 4, 2024 – AstraZeneca’s Imfinzi® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine. <Read More> 

Acetadote® (acetylcysteine) Injection – New Label Expansion – November 26, 2024 – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote® is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen. <Read More> 

Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – November 20, 2024 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). <Read More>  

New Drug Shortage

January 31, 2025

• Epoprostenol Sodium Injection (Discontinuation)

January 30, 2025

• Ramipril Capsule (Discontinuation)

January 28, 2025

• Donepezil Hydrochloride Tablet (Discontinuation)

• Lidocaine Ointment (Discontinuation)

• Lidocaine Ointment (Discontinuation)

• Teriflunomide Tablet (Discontinuation)

January 27, 2025

• Bendamustine Hydrochloride Injection (Discontinuation)

January 24, 2025

• Peginterferon alfa-2a Injection (Currently In Shortage)

Updated Drug Shortage

January 28, 2025

• Amoxapine Tablet (Resolved)

January 27, 2025

• Atropine Sulfate Injection (Currently In Shortage)

• Bupivacaine Hydrochloride Injection (Currently In Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Clindamycin Phosphate Injection (Currently In Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Dextrose 50% Injection (Currently In Shortage)

• Dextrose Monohydrate 5% Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Etomidate Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Acetate Injection (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

• Sterile Water Injection (Currently In Shortage)

January 24, 2025

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Dopamine Hydrochloride Injection (Currently In Shortage)

• Etomidate Injection (Currently In Shortage)

• Fentanyl Citrate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Ketamine Hydrochloride Injection (Currently In Shortage)

• Leucovorin Calcium Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Midazolam Hydrochloride Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Promethazine Hydrochloride Injection (Currently In Shortage)

January 23, 2025

• Amoxapine Tablet (Currently In Shortage)

• Amoxicillin Powder, For Suspension (Currently In Shortage)

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

• Azacitidine Injection (Currently In Shortage)

• Carboplatin Injection (Currently In Shortage)

• Clonazepam Tablet (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently In Shortage)

• Mefloquine Hydrochloride Tablet (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently In Shortage)

• Oxazepam Capsule (Currently In Shortage)

• Streptozocin Powder, For Solution (Currently In Shortage)

January 22, 2025

• Dexmedetomidine Hydrochloride Injection (Currently In Shortage)

• Vecuronium Bromide Injection (Resolved)

New Drug Recall and Safety Alerts

Fentanyl Transdermal System 25 mcg/h by Alvogen – New Voluntary Recall – January 31, 2025 - Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor. <Read More>

Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) by Provepharm Inc. – New Voluntary Recall – January 24, 2025 - Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product. <Read More> 

New Generic/Biosimilar Approval and Launch

Avtozma® (tocilizumab-anoh) Injection – New Actemra® Biosimilar Approval – January 30, 2025 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Avtozma® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra®. Avtozma® is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19). <Read More> 

Steqeyma® (ustekinumab-stba) Injection – New Stelara® Biosimilar Approval – December 17, 2024 - Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. <Read More>  

Yesintek™ (ustekinumab-kfce) Injection – New Stelara® Biosimilar Approval – November 29, 2024 – Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek™ (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab). <Read More> 

Clinical and Pharmacy News

Guidelines Call for Widespread Type 1 Diabetes Screening in Children – February 4, 2025 – A University of Florida Health physician-scientist led an international team of Type 1 diabetes experts who recently developed new treatment guidelines emphasizing wider screening for the disease among children and adolescents in the general population before symptoms arise. That would include screening the young relatives of those with Type 1 diabetes, such as siblings, because they are at higher genetic risk of developing diabetes. The effort was led by Michael Haller, M.D., chief of pediatric endocrinology in the UF College of Medicine's Department of Pediatrics and a member of the UF Diabetes Institute. The guidelines cover screening, staging, and strategies to preserve beta cell function in children and adolescents with Type 1 diabetes. <Read More> 

Trump Tariffs Will Escalate Costs and Disrupt the Medical Supply Chain, Industry Execs Warn – February 3, 2025 – Double-digit tariffs, if they take effect as proposed, threaten to escalate healthcare costs, disrupt supply chains and create affordability challenges for patients, healthcare executives say. President Donald Trump on Saturday signed executive orders intending to impose sweeping tariffs on the country’s three largest trading partners. The Trump administration imposed 25% tariffs on imports from Canada and Mexico plus a 10% tariff on Chinese imports. <Read More> 

Automated Follow-up Alerts Pharmacists to Cancer Patients’ Needs – January 28, 2025 – Early automated follow-up of cancer patients can help pharmacists more efficiently manage side effects of oral oncolytic medications, according to data presented at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans (poster 4-058). To improve adverse event (AE) detection and prevention, a team from Vanderbilt University Medical Center’s Specialty Pharmacy, in Nashville Tenn., sent an electronic early monitoring questionnaire to patients who were starting oral anticancer treatment. The questionnaire, distributed via the patient portal inbox, “resulted in higher [rates of], and faster time to, pharmacists identifying and addressing AEs from newly initiated oral anticancer therapy in patients who responded compared to those who did not respond or were in the usual-care arm,” explained presenter Brooke Looney, PharmD, CSP, the oncology/hematology clinical lead at Vanderbilt. <Read More> 

AI’s Potential in Women’s Health Exciting, Says Gates Foundation Leader – January 21, 2025 – The health disparity between women and men is a pressing global challenge, experts highlighted in a discussion at the World Economic Forum Annual Meeting 2025 in Switzerland. Despite comprising half the global population, women spend 25% more of their lives in poor health compared to men, according to a 2024 report by the World Economic Forum and McKinsey Health Institute. Addressing this gap could not only improve millions of lives, but also add at least $1trn to the global economy annually by 2040, said Anita Zaidi, president of gender equality at the Bill & Melinda Gates Foundation, quoting the report. Innovations in artificial intelligence (AI), digital health tools, and cross-sector collaboration are expected to help bridge this disparity. <Read More> 

Will PBM Reform Save Pharmacies From Closing? – January 15, 2025 – In May 2024, nearly 90% of pharmacies were closed for a day as thousands of pharmacists protested over “over drug shortages, pharmacy closures and fears medications could be sold online, as well as higher pay.” More recently in November 2024, pharmacy owners voted in favor of cutting hours and stopping home deliveries in a protest over funding. Given multiple recent news articles saying that pharmacies are struggling amid problems caused by pharmacy benefit managers (PBMs) , you might not be surprised by these examples. However, these two news stores are not from the U.S. They are from France and the United Kingdom — two countries that do not have the large PBMs that are frequently criticized in America. <Read More> 

Despite Risks and Scant Evidence, Muscle Relaxants Still Used to Treat Chronic Pain – January 14, 2025 – The CDC has guidelines recommending that clinicians avoid using opioids to manage chronic noncancer pain. Now data published in JAMA Network Open indicate that as physicians heed opioid guidelines, prescriptions for skeletal muscle relaxants (SMRs) for chronic pain have risen—despite risks posed by SMRs and a lack of evidence supporting their long-term use (JAMA Network Open 2024;7[9]:e2434835). “This means that, when thinking about using muscle relaxants for chronic pain conditions, we should be vigilant and cautious,” said study author Benjamin J. Oldfield, MD, an internal medicine/pediatric specialist at the Yale School of Medicine, in New Haven, Conn. “As physicians, it may not be the right option to prescribe, and to continue to refill, muscle relaxants for the majority of chronic pain conditions.” <Read More> 

Drugmakers Hiked Prices for Hundreds of Drugs in Early January – January 14, 2025 – Drugmakers raised the list prices on 575 name-brand drugs in just the first two days of the new year, according to drug price research firm 46brooklyn. Drugs for diabetes, HIV, cancer saw price hikes, among others. For years a 10% annual price hike was fairly normal, but they've started coming down in recent years. This year's median price hike so far is only 4%, says Antonio Ciaccia, CEO of 46brooklyn. "While it's early, if that number held throughout the year, that would make it the lowest median price increase in over a decade," says Ciaccia. January is typically a popular time to raise prices on brand name drugs, but companies can raise them throughout the year. There could even be more later this month, he says. <Read More> 

Clearing the Path for New Uses for Generic Drugs – January 9, 2025 – Repurposing generic drugs as new treatments for life-threatening diseases is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. The low profit margins for generic drugs mean that pharmaceutical companies rarely invest in research, regulatory efforts, and marketing for new uses. Nonprofit organizations and other non-commercial non-manufacturers are increasing efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. <Read More> 

Pharmacological Treatment in Autism: A Proposal for Guidelines on Common Co-Occurring Psychiatric Symptoms – January 7, 2025 – The prevalence of autism spectrum disorder (ASD) has surged, with an estimated 1 in 36 eight-year-olds in the United States meeting criteria for ASD in 2020. Autistic individuals face elevated rates of co-occurring medical, psychiatric, and behavioral conditions compared to non-autistic individuals. The rising ASD-patient demand is increasingly outpacing the capacity of ASD-specialty clinics, resulting in urgent need for autism-competent providers in general practice settings. This work aims to empower healthcare providers, especially primary care providers (PCPs), with guidelines for the recognition and safe pharmacologic management of common co-occurring psychiatric and behavioral conditions in ASD. <Read More> 

Senate Introduces Bipartisan Bill to Ban Co‑ownership of Pharmacies and Pharmacy Benefits Managers – December 13, 2024 – Senators Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., introduced in the Senate the Patients Before Monopolies Act (PBM Act), a bill “[t]o prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes.” The PBM Act would make it unlawful for any person to “own, operate, control, or direct the operation of” any type of pharmacy if that person also “own[s], operate[s], or control[s]” an insurance company or pharmacy benefits manager (PBM). This bill follows nearly a year of heightened government scrutiny of PBMs and allegations of harm resulting from vertical integration and price fixing. If passed, the PBM Act would prevent PBMs and payors from being in a position of control over pharmacies through which they can affect the competitive harms alleged. <Read More> 

Drugmakers and Pharmacists Battle Over Who Gets to Make Obesity Drugs – December 12, 2024 – Ozempic® and similar drugs for Type 2 diabetes and weight loss are in such high demand that the drugmakers have had a hard time keeping up. So compounding pharmacies stepped in to fill the gap, making their own versions of the drugs for more than two years. The compounded versions are especially popular as cheaper alternatives for people whose insurance doesn't cover them. But now the brand name manufacturers are pushing the compounding pharmacies to stop. Novo Nordisk and Eli Lilly are moving to end compounding of their medicines for good. <Read More> 

Pharmacists’ Key Role in the Management of Humira Biosimilars – November 27, 2024 – The introduction of adalimumab (Humira®, AbbVie) biosimilars to the US market in 2023 brought significant changes for providers, patients, and pharmacies. Since its introduction in 2002, Humira has been one of the world’s bestselling drugs for treating inflammatory conditions…Pharmacists have been challenged in managing the complexity of switching patients from the reference product to various biosimilars, including navigating clinical appropriateness, education, insurance, affordability, and several practical hurdles. We aim to provide an update on what is new, what we have learned over the past 12 months, and what we are anticipating in the Humira biosimilar market. <Read More> 

ASTRO Releases Updated Guidelines for Treating Locally Advanced Rectal Cancer – November 25, 2024 – The American Society for Radiation Oncology (ASTRO) issued an updated clinical guideline for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. This update incorporates new data on patient selection and best practices from several practice-changing clinical trials published since the prior guideline was issued in 2020. The updated ASTRO guideline is published in Practical Radiation Oncology. <Read More> 

Top Three Pharmacy Benefit Managers Will Face FTC in Joint Trial for Insulin Rebate Cases – November 20, 2024 – Administrative Law Judge D. Michael Chappell ordered that the country’s largest pharmacy benefit managers (PBMs) have to face the FTC together in an administrative case. The case alleges that the three largest PBMs―Caremark, Express Scripts and OptumRX―used unfair rebate schemes to artificially inflate the price of insulin. In mid-October, the PBMs each moved for separate proceedings, arguing that a consolidated trial could create confusion. The judge held that the factual differences in each of the cases were “minimal and manageable.” Judge Chappell noted that many of the respondents’ arguments regarding confusion of the evidence cited to authority regarding jury trials, but the current case is a bench trial. <Read More> 

Market Trends to Watch for Health Systems and Their Specialty Pharmacies – November 18, 2024 – The overall market for specialty medications has grown dramatically over the past decade, and that trend is expected to continue for at least the next five years. Health systems, patients and pharmacies will experience shifting market dynamics that add challenges to providing specialty care, including price increases, an aging population driving increased utilization and a growing wave of innovative therapies that add new patients to the specialty pool. In response, health systems have sharpened their focus on integrating specialty pharmacy care to now include pharmacy needs within their hospitals to help improve patient outcomes and experiences. <Read More> 

Management of Stage III Non–Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update Clinical Insights – November 18, 2024 – Stage III non–small cell lung cancer (NSCLC) is a highly heterogeneous disease with a range of treatment options that have been highlighted in the ASCO guidelines (Figs 1 and 2).1-3 Historically, treatment was largely determined by resectability and nodal extent, without personalization on the basis of molecular subtype. Several recent trials favor molecular profile–guided precision therapy of both resectable and unresectable stage III NSCLC: highlighting the need for guideline-concordant biomarker testing for all patients with stage III NSCLC. In addition, new data address incorporation of perioperative immunotherapy, expanding treatment options for patients with resectable disease. This article provides additional context and insight into common clinical situations encountered by oncologists with a review of recent trials that update the standard of care for both resectable and unresectable stage III NSCLC. <Read More>

340B in the News

New Administration’s Impact on 340B Program: TBD – January 16, 2025 – How could the second Trump administration affect the federal 340B Drug Pricing Program? It’s yet to be determined, according to policy experts. Predicting how the election could ultimately affect the program “is above my pay grade,” joked Maureen Testoni, JD, the president and CEO of 340B Health, a nonprofit organization representing more than 1,500 hospitals and health systems that participate in the 340B program. However, during President-elect Donald Trump’s prior term, “we didn’t see a lot of action on 340B,” she said in a Nov. 19 press briefing. Early on in that administration, Medicare cut its reimbursement for Part B 340B drugs by nearly 30% and redistributed the money through higher payments for nondrug services to all hospitals paid under the Medicare Outpatient Prospective Payment System, Ms. Testoni said. But hospital associations sued over the cuts, and the U.S. Supreme Court overturned them in 2022. <Read More>