Generic drugs approved by FDA (through July 2010): Naratriptan hydrochloride tablets, Famotidine for oral suspension, Adapalene cream, Enoxaparin sodium injection, Oxymorphone hydrochloride
Naratriptan hydrochloride tablets in the 2.5-mg strength (equiv to Amerge)
SANDOZ
Famotidine for oral suspension, 40 mg/5 mL (equiv to Pepcid)
LUPIN
Adapalene cream in the 0.1% strength (equiv to Differin)
FOUGERA AND GLENMARK
Oxymorphone hydrochloride (equiv to Opana) extended-release 30-mg tablet in 5-mg, 10-mg, 20-mg, and 40-mg tablets.
IMPAX LABORATORIES
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.