New Drug/Vaccine Approval

No new update.

New Indication/Dosage/Formulation Approval

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – January 30, 2024 – Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days. <Read More> Gammagard Liquid® (immune globulin infusion (human)) Solution – New Label Expansion – January 26, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved Gammagard Liquid® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be used as induction therapy, which includes an induction dose followed by maintenance doses. For treatment of CIDP, Gammagard Liquid® has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months. <Read More> Dupixent® (dupilumab) Injection – New Label Expansion – January 25, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent® is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent® for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. <Read More> Zynrelef® (bupivacaine and meloxicam) Injection – New Label Expansion – January 23, 2024 – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for Zynrelef® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Zynrelef® was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. <Read More>

New Drug Shortage

February 06, 2024

• Carbamazepine Capsule, Extended Release (Discontinuation)

• Mesalamine Tablet, Delayed Release (Discontinuation)

February 01, 2024

• DOXYCYCLINE HYCLATE CAPSULE (Discontinuation)

January 30, 2024

• Erythromycin Ointment (Currently in Shortage)

• Triazolam Tablet (Discontinuation)

January 26, 2024

• Riluzole Oral Suspension (Currently in Shortage)

• Zolpidem Tartrate Tablet, Extended Release (Discontinuation)

January 24, 2024

• Lidocaine Hydrochloride Solution (Currently in Shortage)

Updated Drug Shortage

February 06, 2024

• Amoxapine Tablet (Currently in Shortage)

• Azacitidine Injection (Currently in Shortage)

• Capecitabine Tablet (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Disopyramide Phosphate Capsule (Currently in Shortage)

• Fludarabine Phosphate Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

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

• Neomycin Sulfate Tablet (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

February 05, 2024

• Capecitabine Tablet (Currently in Shortage)

• Dulaglutide Injection (Currently in Shortage)

• Liraglutide Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Discontinuation)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Methyldopa Tablet, Film Coated (Discontinuation)

February 03, 2024

• Amino Acid Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

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

• Mannitol 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)

February 02, 2024

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

February 01, 2024

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

• Atropine Sulfate Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

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

• Flurazepam Hydrochloride Capsule (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Hydroxypropyl Cellulose (1600000 Wamw) Insert (Currently in Shortage)

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Mannitol Injection (Currently in Shortage)

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

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Nitroglycerin Injection (Currently in Shortage)

• Potassium Chloride Injection (Currently in Shortage)

• Rocuronium Bromide 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)

• Sucralfate Tablet (Currently in Shortage)

• Sulfasalazine Tablet (Currently in Shortage)

• Valproate Sodium Injection (Currently in Shortage)

• Vecuronium Bromide Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

January 31, 2024

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

New Drug Recall and Safety Alerts

Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg by Azurity Pharmaceuticals, Inc. - New Voluntary Recall – January 25, 2024 – Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed. <Read More> Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products by Haleon – New Voluntary Recall – January 24, 2024 – Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid™ – January 29, 2024 – The FDA is announcing a revision to the Paxlovidä emergency use authorization (EUA), stating that Paxlovid™ manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid™) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. <Read More> US Pharmacy Benefit Lobby Group Ramps Up Spending as Lawmakers Close in – January 25, 2024 – As U.S. pharmacy benefit companies face scrutiny from lawmakers and regulators, the main group representing them in Washington has nearly doubled its lobbying spend to over $15 million in 2023, a Reuters review of congressional disclosures shows. That puts them behind only the $27 million spent by the Pharmaceutical Research and Manufacturers of America (PhRMA), the usual No. 1 and main lobby group for drugmakers that has tried to deflect criticism for high drug prices by blaming the industry's middlemen, the pharmacy benefit managers (PBMs). <Read More>

340B in the News

Senators Seek Stakeholder Feedback on Draft 340B Legislation – February 2, 2024 – A bipartisan group of senators Feb. 2 released for stakeholder feedback a discussion draft of legislation to clarify in statute Congress’ intent for the 340B program to help safety net providers maintain, improve and expand patient access to health care services by requiring drug manufacturers that participate in Medicaid and Medicare Part B to provide discounts and rebates to covered entities that serve a disproportionate share of low-income and underserved patients. <Read More>