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Clinical Insights: February 7, 2024

Posted on February 7, 2024 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

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

February 01, 2024

January 30, 2024

January 26, 2024

January 24, 2024

Updated Drug Shortage

February 06, 2024

February 05, 2024

February 03, 2024

February 02, 2024

February 01, 2024

January 31, 2024

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>