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.
Novo Nordisk Terminates Collaboration with Hims & Hers
June 23rd 2025The FDA had resolved the shortage of Wegovy in April, and telehealth providers were advised to stop selling compounded semaglutide products. Novo Nordisk said that Hims & Hers continues to offer these compounded drugs.
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