AMRX - Amneal gets FDA nod for 4 generic injectables products

The U.S. Food and Drug Administration (FDA) approved  four generic injectables products from Amneal Pharmaceuticals (NYSE:AMRX). Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, received abbreviated new drug application (ANDA) approval from the FDA. The company said dexamethasone and azacitidine are currently on the FDA drug shortage list, and atroprine was granted competitive generic therapy (CGT) status by the FDA. Amneal (AMRX) noted that it ~25 commercial injectables for the U.S. institutional market and is targeting over 40 launches from 2021 to 2025 in several areas, such as drug/device combinations, peptides, long acting injectables and large volume parenteral bags.

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Amneal gets FDA nod for 4 generic injectables products