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First-time generic approvals May 2010
Generic drugs approved by FDA (through April 2010): Losartan potassium tablets in 25-mg, 50-mg, and 100-mg, Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg, Hydromorphone hydrochloride injection, Mesna injection
Losartan potassium tablets in 25-mg, 50-mg, and 100-mg strengths (equiv to Cozaar)
TEVA PHARMACEUTICALS
Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg strengths (equiv to Hyzaar)
Hydromorphone hydrochloride injection 10 mg/mL in 1-, 5-, and 50-mL doses (equiv to Dilaudid-HP 10 mg/mL injection)
AKORN
Mesna injection in 1 mg per 10 mL multi-dose vials (equiv to Mesnex)
STRIDES ARCOLAB
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.
