Generic drugs approved by FDA (through June 2008) including epoprostenol for injection, ropinirole, donepezil, and drospirenone/ethinyl estradiol.
Epoprostenol for injection, 0.5 and 1.5 mg base/vial (equiv to Flolan for injection)
TEVA
Ropinirole tablets, 0.25, 0.5, 1, 2, 3, and 4 mg (equiv to Requip tablets)
ROXANE, TEVA, PAR, MYLAN
Donepezil tablets, 5 and 10 mg (equiv to Aricept tablets)
TEVA
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.