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FDA actions in brief, February 2010 (Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose)
Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose
Dalfampridine extended release tablets (Ampyra, Acorda Therapeutics) was approved to improve walking in patients with multiple sclerosis.
Liraglutide once-daily injection (Victoza, Novo Nordisk) was approved for treatment of type 2 diabetes in some adults.
Tocilizumab (Actemra, Roche Holding) was approved for moderate to severe rheumatoid arthritis in adults who have not achieved an adequate response with one or more tumor necrosis factor antagonist therapies.
Morphine sulfate oral solution (Roxane Laboratories) in the 100-mg-per-5-mL and 20-mg-per-mL strengths was approved for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients.
Inactivated influenza virus vaccine (Fluzone High-Dose, Sanofi Pasteur) was approved for active immunization of people 65 and older.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
