US Pharm. 2024;49(10):58.

FDA Approves Propofol IV Emulsion Single-Dose Vials

Amneal Pharmaceuticals, Inc., announced that it received Abbreviated New Drug Application approval from the FDA for Propofol Injectable Emulsion, USP, in 200-mg/20-mL (10-mg/mL), 500-mg/50-mL (10-mg/mL), and 1,000-mg/100-mL (10-mg/mL) single-dose vials.

Propofol is an IV drug that is commonly used in hospitals for the induction and maintenance of anesthesia and sedation. Propofol is an essential surgical anesthetic in hospitals that is in chronic shortage. It is currently on the American Society of Health-System Pharmacists drug shortages list and has a history of shortage due to supply-chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. The company expects to launch propofol in the fourth quarter of 2024.

Voranigo Approved for Grade 2 Astrocytoma or Oligodendroglioma

The FDA recently approved Servier Pharmaceuticals’ Voranigo (vorasidenib)—an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor—for adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, subtotal resection, or gross total resection. This is the first approval by the FDA of a systemic therapy for patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

First Ready-to-Use Bortezomib Approved

Amneal Pharmaceuticals, Inc., and Shilpa Medicare Limited recently announced that the FDA approved Boruzu (bortezomib injection)—a new presentation of bortezomib for ready-to-use (RTU) SC or IV administration. Boruzu, a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This new RTU oncology product reduces the compounding preparation steps that are typically required with administration.

The most commonly reported adverse reactions for Boruzu in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Boruzu is expected to launch with a unique J-code in the second quarter of 2025.

FDA Approves Lazcluze, Amivantamab Combination for NSCLC

The FDA has approved Janssen Biotech’s Lazcluze (lazertinib) in combination with Rybrevant (amivantamab-vmjw) for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The recommended lazertinib dosage is 240 mg orally once daily administered in combination with amivantamab with or without food. The recommended amivantamab dose is based on baseline body weight.

Zyrtec Reintroduces Dissolvable Tablets

Zyrtec reintroduced its Dissolve Tabs in time for fall allergy season—a 10-mg tablet that dissolves instantly and starts working at hour 1 against indoor and outdoor allergies. Zyrtec Dissolve Tabs provide 24-hour relief. Zyrtec Dissolve Tabs have a citrus flavor and help treat allergy symptoms, including runny nose, sneezing, and itchy, watery eyes, nose, and throat. Zyrtec Dissolve Tabs are available for adults and children aged 6 years and older and can be purchased at all major retailers and pharmacies in the United States.

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