New Drug/Vaccine Approval

Kisunla™ (donanemab-azbt) Injection – New Drug Approval – July 2, 2024 – The U.S. Food and Drug Administration has approved Kisunla™ (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla™ should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials. Kisunla™ is administered as an intravenous infusion every four weeks. <Read More> Ohtuvayre™ (ensifentrine) Inhalation Suspension – New Drug Approval – June 26, 2024 – Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre™ is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. Ohtuvayre™ is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre™ is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. <Read More> Tepylute™ (thiotepa) Injection – New Drug Approval – June 25, 2024 – The US Food and Drug Administration (FDA) has approved specialty pharmaceutical company Shorla Oncology’s new drug application (NDA) for Tepylute™, a new formulation to treat breast and ovarian cancer. Tepylute™ is the third drug in the company’s portfolio to obtain FDA approval, with several other cancer drugs awaiting approval for the US market. Previously known as SH-105, the asset is a ready-to-dilute, injectable product that simplifies preparation and ensures dosing accuracy for breast and ovarian cancer treatments. <Read More> PiaSky® (crovalimab-akkz) Injection – New Orphan Drug Approval – June 24, 2024 - The U.S. Food and Drug Administration (FDA) has approved PiaSky® (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. <Read More>

New Indication/Dosage/Formulation Approval

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – July 9, 2024 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve® (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Zoryve® is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control. <Read More> Vabysmo® (faricimab-svoa) Intravitreal Injection – New Label Expansion – July 3, 2024 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to three million people in the U.S. The Vabysmo® PFS will become available to U.S. retina specialists and their patients in the coming months. <Read More> Epkinly™ (epcoritamab-bysp) Injection – New Label Expansion – June 26, 2024 – The Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly™, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. <Read More>

New Drug Shortage

July 17, 2024

• Isoniazid Tablet (Currently in Shortage)

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

July 12, 2024

• Cyanocobalamin Spray (Discontinuation)

July 11, 2024

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

July 03, 2024

• Sodium Benzoate; Sodium Phenylacetate Injection (Discontinuation)

July 02, 2024

• Betaxolol Hydrochloride Ophthalmic Suspension (Discontinuation)

• Quinapril Hydrochloride Tablet (Currently in Shortage)

Updated Drug Shortage

July 19, 2024

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

July 18, 2024

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

July 17, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

July 16, 2024

• Leucovorin Calcium Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

July 15, 2024

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

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Epinephrine Injection, Syringes (Currently in Shortage)

• Etomidate 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)

• Hydrocortisone Sodium Succinate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketamine Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (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)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Potassium Acetate Injection (Currently in Shortage)

• Quinapril Hydrochloride Tablet (Currently in Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

• Rocuronium Bromide 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 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sucralfate Tablet (Resolved)

• Sufentanil Citrate Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

Clonazepam Orally Disintegrating Tablets, USP (C-IV) by Endo USA, Inc. – New Voluntary Recall – July 16, 2024 - Endo, Inc (OTCQX: NDOI) (“Endo”), announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level. The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. <Read More> Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K by American Health Packaging on Behalf of BluePoint Laboratories – New Voluntary Recall – June 26, 2024 - American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. <Read More> Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K by Glenmark Pharmaceuticals Inc – New Voluntary Recall – June 24, 2024 - Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. <Read More>

New Generic/Biosimilar Approval and Launch

Pyzchiva® (ustekinumab-ttwe) Injection - New Biosimilar Approval – June 28, 2024 – Sandoz, the global leader in generic and biosimilar medicines, announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva® (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the US. In addition, the FDA provisionally determined that Pyzchiva® would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products… Pyzchiva® is approved by the FDA for all indications of the reference medicine Stelara® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist. <Read More> Ahzantive® (aflibercept-mrbb) Injection - New Biosimilar Approval – June 28, 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) announce that the U.S. Food and Drug Administration (“FDA”) approved FYB203/Ahzantive® (aflibercept-mrbb), a biosimilar to Eylea®. FYB203/Ahzantive® obtained FDA approval for the treatment of patients with neovascular Age-Related (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO). <Read More> Nypozi® (filgrastim-txid) Injection – New Biosimilar Approval – June 28, 2024 – The FDA approved Tanvex’s Nypozi® (filgrastim-txid), biosimilar to Amgen’s Neupogen™ (filgrastim). Nypozi® is the fourth FDA-approved biosimilar to Neupogen™. Zarxio® (filgrastim-sndz), Nivestym® (filgrastim-aafi) and Releuko® (filgrastim-ayow) have all previously launched. <Read More>

Clinical and Pharmacy News

AI Will Change Pharmacy; Pharmacists Must Step Up Now – July 17, 2024 – At the first-ever ASHP Artificial Intelligence Summit, in Portland, Ore., pharmacy leaders discussed innovative uses of the technology. “I see tremendous opportunity for the digital enhancement of medication management, pharmacy practice and healthcare as a whole,” Lisa Stump, MS, the chief information officer at Yale Medicine and Yale New Haven Health, in Connecticut, said to kick off the summit. Although definitions of AI vary, ASHP uses a version from the Oxford English Dictionary: “The capacity of computers or other machines to exhibit or simulate intelligent behavior.” AI systems use mathematics to, for example, make predictions of the next word in a string of words, or deduce whether an image is a dog or cat, based on training data that humans have given it. The training data can have few variables or many. It enables AI to spot patterns such as changes to the timbre of someone’s voice or fluctuations in their blood pressure. <Read More> CGTs ‘a Big Deal for Pharmacy,’ So Getting Payment Right is Crucial – July 17, 2024 - A growing number of cell and gene therapies offer significant symptom relief—and in some cases, even cures—for a wide range of often debilitating conditions. But at millions of dollars per dose, CGT treatments pose demanding procurement and reimbursement challenges for U.S. hospitals that are qualified to administer them. Several health systems are rising to that challenge. Some are partnering with consultants with proven expertise in securing prior authorizations for CGTs. Others have developed in-house pharmacy and therapeutics (P&T) committees that specialize in managing CGTs. The common thread to these efforts is having clearly defined processes for clearing the considerable clinical, financial and operational hurdles posed by these groundbreaking therapies. <Read More> FTC Reportedly to Sue Three Largest Pharmacy Benefit Managers – July 11, 2024 – The Federal Trade Commission is preparing to sue the largest three pharmacy benefit managers over their negotiations over the prices for drugs including insulin, The Wall Street Journal reported on Wednesday. The FTC plans to file lawsuits related to rebates brokered with drug manufacturers, people familiar with the matter told the WSJ. The three largest PBMs are UnitedHealth Group's OptumRx, Cigna's Express Scripts and CVS Health's CVS Caremark. These three account for an estimated 80% of prescriptions. The news of a lawsuit comes on the heels of an FTC report on pharmacy benefit managers. The FTC did a two-year investigation into their practices and released the FTC report, "Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies." <Read More> An Examination of the Cholesterol Hypothesis – July 11, 2024 – Most cardiologists and lipid experts have long subscribed to the “cholesterol hypothesis” (also called “lipid hypothesis”). The cholesterol hypothesis, simply stated, is that an elevated blood level of LDL cholesterol is a direct cause of atherosclerosis, a progressive disease where arteries become clogged with plaque. As a result, the medical community’s consensus has been to help people reduce LDL cholesterol levels to lower the risk of atherosclerotic cardiovascular disease. However, more recently, experts have been questioning the cholesterol hypothesis. This article explains the theory, its implications, and factors besides cholesterol that researchers are considering. <Read More> Alzheimer's: Revised Diagnostic Criteria Place Blood Biomarkers at the Forefront – July 4, 2024 – About 32 million people around the world are currently living with Alzheimer’s disease. Better outcomes are linked to early Alzheimer’s disease diagnosis. A workgroup from the Alzheimer’s Association has published revised criteria for the diagnosis and staging of the condition based on the biology of the disease and the latest research. <Read More> Daily Aspirin Use Among Older Adults Remains Prevalent Despite Potential Risks – July 2, 2024 – Aspirin is a common over-the-counter medication that can help relieve pain and reduce the risk of blood clots. Past recommendations have included taking aspirin to help prevent cardiovascular disease. Recent guidance indicates that adults over 70 should not use aspirin for primary prevention of heart disease. A recent survey found the number of adults using aspirin to prevent heart disease has decreased, but around one-third of adults ages 60 and older without heart disease were still taking aspirin, some without medical advice. <Read More>

340B in the News

Protecting Federally Qualified Health Centers Amid Drugstore Closures and Threats to 340B – July 15, 2024 - In January 2024, a Walgreens location in Roxbury, Massachusetts, a predominantly Black and Latinx neighborhood in Boston, closed despite local grassroots activism and congressional support to keep it open. The shuttered store follows a series of Walgreens closures in the Roxbury, Mattapan, and Hyde Park neighborhoods of Boston… Unfortunately, proposed restrictions on the number of pharmacies that can partner with 340B-covered entities is an emerging challenge to improving pharmacy access. When FQHCs do not have an in-house pharmacy or when their patient base is spread across a wider geographic area, they typically contract with multiple pharmacies in various locations to provide the most convenience to their patients. Patients can then choose which pharmacy to pick up their medications. <Read More>