FDA actions in brief, March 2009 (Gelnique, RiaSTAP, Kapidex)
Recent FDA approvals (through March 2009) related to Gelnique, RiaSTAP, and Kapidex
Oxybutynin gel 10% (Gelnique, Watson) was approved for the topical treatment of overactive bladder.
Fibrinogen concentrate (human) (RiaSTAP, CSL Behring) was approved for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Dexlansoprazole delayed-release capsules (Kapidex, Takeda) were approved for the once-daily treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE), and the maintenance of healed EE.
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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