FDA approves sANDA for Glenmark Pharmaceuticals’ Monroe facility
PARAMUS, N.J. — Glenmark Pharmaceuticals announced that the U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company’s manufacturing facility in Monroe, N.C. The approval covers: atovaquone and proguanil hydrochloride tablets, 250 mg/100 mg and 62.5 mg/25 mg, a generic version of GlaxoSmithKline’s Malarone (atovaquone and proguanil hydrochloride)
