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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 Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
