New Drug/Vaccine Approval

Myhibbin™ (mycophenolate mofetil) Oral Suspension – New Drug Approval – May 1, 2024 – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response. In 2023, there were over 46,000 transplants in the US and these patients need to take medication every day to fight against rejection. Myhibbin™ is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants. <Read More>

New Indication/Dosage/Formulation Approval

Altuviiio® (antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl) Lyophilized Powder for Injection – New Label Expansion – May 10, 2024 – The US Food and Drug Administration (FDA) has updated the label for Altuviiio® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] to include full results from the phase 3 XTEND-Kids study showing that once-weekly dosing with Altuviiio® delivers highly effective bleed protection in children with hemophilia A. <Read More> Ingrezza® (valbenazine) Capsules – New Label Expansion – April 30, 2024 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced the U.S. Food and Drug Administration has approved Ingrezza® Sprinkle (valbenazine) capsules, a new oral granules formulation of Ingrezza® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. Ingrezza® Sprinkle provides an alternative administration option for those who experience dysphagia or have difficulty swallowing. <Read More> Cyltezo® (adalimumab-adbm) Injection – New Label Expansion – April 30, 2024 - Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) to treat multiple chronic inflammatory diseases…The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira® under the brand name Cyltezo® and at an 81% discount to Humira as the unbranded product adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo® has been commercially available since July 2023. <Read More> Tivdak® (tisotumab vedotin-tftv) Lyophilized Powder for Injection – New Label Expansion – April 29, 2024 – Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for Tivdak® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. <Read More> Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets – New Label Expansion – April 24, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. <Read More>

New Drug Shortage

May 09, 2024

• Iloprost Solution (Discontinuation)

May 03, 2024 

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

May 02, 2024

• Barium Sulfate Suspension (Discontinuation)

April 30, 2024

• Albuterol Sulfate Powder, Metered (Discontinuation)

• Clomipramine Hydrochloride Capsule (Discontinuation)

• Doxycycline Hyclate Tablet (Discontinuation)

• Fesoterodine Fumarate Tablet, Extended Release (Discontinuation)

• Fluticasone Propionate Powder, Metered (Discontinuation)

• Fluticasone Propionate; Salmeterol Xinafoate Powder, Metered (Discontinuation)

• Temazepam Capsule (Discontinuation)

Updated Drug Shortage

May 13, 2024

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dextrose Monohydrate, Lidocaine Hydrochloride Anhydrous Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sodium Chloride 0.9% Irrigation (Currently in Shortage)

• Sterile Water Irrigant (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

May 08, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bumetanide Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Cefotetan Disodium Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dacarbazine Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dulaglutide Injection (Currently in Shortage)

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

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sodium Chloride 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Tirzepatide Injection (Currently in Shortage)

May 07, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Hydroxocobalamin Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Potassium Chloride Injection (Resolved)

May 06, 2024

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

• Azacitidine Injection (Currently in Shortage)

• Capecitabine Tablet (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

May 02, 2024

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

• Digoxin Injection (Resolved)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

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

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Hercessi™ (trastuzumab-strf) – New Biosimilar Approval – April 29, 2024 - Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Hercessi™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. <Read More>

Clinical and Pharmacy News

Hormone Therapy, Vitamin Supplementation in Postmenopausal Women did not Decrease Risk of Cancer, Chronic Disease – May 13, 2024 – The origination of the Women’s Health Initiative (WHI) in 1993 occurred when observational studies had reported that postmenopausal women who underwent hormone therapy experienced lower risks of coronary heart disease (CHD), bone fractures, and all-cause mortality compared with those who did not undergo hormone therapy. Additionally, hormone therapy was also being used more frequently to prevent cardiovascular (CVD) and other chronic diseases for both women in early and late menopause; however, no randomized controlled trials (RCTs) assessed the benefits or risks of hormone therapy for chronic disease prevention. Further, supplementation with calcium plus vitamin D were believed to reduce fractures and those with certain dietary patterns were believed to experience higher rates of breast and colorectal cancer. <Read More> Hypertrophic Cardiomyopathy Guidelines add Drug Class, Endorse More Exercise – May 8, 2024 – Updates to national guidelines for the management of hypertrophic cardiomyopathy (HCM) endorse cardiac myosin inhibitor use in certain cases, greenlight more intensive physical activity, and expand treatment options for young patients. The American College of Cardiology (ACC) and the American Heart Association (AHA) published the guideline in the Journal of the American College of Cardiology in a new tab or window and Circulation in a new tab or window, respectively. "Recommendations for physical activity continue to evolve with research," Guideline Committee Chair Steve R. Ommen, MD, director of the Mayo Hypertrophic Cardiomyopathy Clinic in Rochester, Minnesota, said in a press release from the two organizations. <Read More> New Clinical Guidance for Sjögren-Related Neuropathy – May 8, 2024 – New guidelines to manage peripheral neuropathy related to Sjögren disease have been developed by a multidisciplinary team of physicians from across medicine. The guidelines will provide an evidence-based resource for the assessment, diagnosis, and treatment of various peripheral neuropathies related to the disorder. Up until now, the field has been "haphazard and chaotic," lead author George Sarka, MD, DrPH, MPH, director of the CME Committee for MemorialCare, Saddleback Medical Center, Laguna Hills, California, and member of the Sjögren's Foundation PNS Guidelines Topic Review Group (TRG), told Medscape Medical News. <Read More Pharmacy AI Set to Grow as Companies Look to Streamline – May 7, 2024 – The robots are coming — to a pharmacy near you. As the world looks to streamline healthcare, the pharmacy automation market is poised to be just what the doctor ordered, with a new report projecting the industry to dispense a hefty $12.7 billion by 2028. The report highlights the demand for pharmacy automation technologies, driven by factors such as rising prescription volumes, the need for automated packaging and labeling solutions, and the effort to reduce medication errors. It’s part of a trend where pharmacies of all sizes are embracing artificial intelligence (AI) to streamline operations and enhance patient experiences. <Read More> Amazon, CVS, Walgreens and Walmart Push to let Pharmacists Prescribe Drugs – May 1, 2024 – Many are pushing for more ways pharmacists can prescribe medications as drugs become increasingly specialized and a shortage of primary care physicians threatens quick access to medical care. But a battle is emerging between the biggest names in pharmacy, which are backing more provider and prescribing status for pharmacists, and doctor groups that oppose the push, saying it’s driven by pharmacy chains prioritizing profits over drugs. Retail pharmacy giants and operators of specialty pharmacies including CVS Health, Walgreens, Walmart and Amazon already have their pharmacists prescribing certain medications like antivirals used against the coronavirus. <Read More> Why are Specialty Drug Costs Increasing and What is its Impact on Payers and Risk Managers? – April 30, 2024 – The rising costs of specialty drugs in the US can be traced to these three separate phenomena: the demand for gene therapy drugs, pharmaceutical interest in making more money, and marketing laws. “A lot of times these pharmaceutical companies are incentivized to come up with new drugs because they’re protected by the 20-year R&D clauses in the US. This is an area they can make money in,” said Mike Gold, senior sales executive at Verikai. <Read More>

340B in the News

Public, Not Nonprofit Hospitals use 340B to Expand Services – May 9, 2024 – A new study published in JAMA Health Forum finds participation in the 340B Drug Pricing Program helps public but not nonprofit hospitals sustain unprofitable service lines, like psychiatric services. The 340B program helps safety-net providers stretch federal resources through discounts on approved outpatient drugs. Through these discounts provided by pharmaceutical companies, the federal program aims to improve access for eligible patients and support the delivery of more comprehensive services. Participation in the 340B program has increased substantially over the past two decades. However, critics have argued that safety-net hospitals have not expanded access and/or provided more services in response to 340B savings. <Read More> A 340B Compromise at Last? Draft Federal Legislation May Provide a Clear Path Forward – May 6, 2024 – In an ambitious effort to address the ongoing uncertainty within the 340B Program space, 6 senators released a draft discussion bill earlier this year titled the SUSTAIN Act. It continues to be an eventful and tumultuous time in the 340B Drug Pricing Program space, with little indication that the current environment will change any time soon. Numerous drug manufacturers continue to impose restrictive 340B pricing policies available via 340B contract pharmacy arrangements in contravention of the Health Resources and Services Administration's (HRSA) applicable 340B Program rules and guidance. Ongoing litigation over these manufacturer restrictions, along with separate litigation challenging HRSA’s historic 340B eligible patient requirements,1 has further eroded the agency’s enforcement authority and created significant uncertainty surrounding the manner in which different types of 340B stakeholders can (or must) operate. Increased scrutiny on 340B covered entities’ savings utilization has also become a flashpoint. <Read More>