FDA actions in brief, May 2008
Recent FDA approvals and indications (through May 2008) related to Janumet, PegIntron, Rebetol, Xyzal, Liquadd, and NovoLog.
The labeling for sitagliptin/metformin (Janumet, Merck) was updated to reflect an expanded indication. The agent is now approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.
FDA approved labeling changes for peginterferon alfa-2b (PegIntron, Schering-Plough) and ribavirin (Rebetol, Schering-Plough) as combination therapy for the treatment of chronic hepatitis C infection. The labels now recommend weight-based dosing of ribavirin (800–1,400 mg/d) and a shorter 24-week course of the combination therapy for patients with chronic hepatitis C virus genotype 2 or 3. An oral solution of levocetirizine (Xyzal, UCB) was approved for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged ≥6 years.
FDA approved dextroamphetamine oral solution, 5 mg/5 mL (Liquadd, Auriga) for the treatment of attention- deficit/hyperactivity disorder (ADHD).
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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