New & Noteworthy

April 2022

Generic Injectables

Amneal Pharmaceuticals

Amneal Pharmaceuticals announces the approval of four new generic injectables products. 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 have received Abbreviated New Drug Application (ANDA) approval from the US FDA. Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy (CGT) status by the FDA. Dexamethasone is a bioequivalent and therapeutically equivalent generic to the reference standard dexamethasone sodium phosphate injection, USP 10 mg/mL. Azactidine is the generic equivalent for Vidaza Injection 100 mg. Carboprost is a generic version of the prostaglandin Hemabate injection, 250 mcg/mL. Atropine is an anticholinergic agent. It is a bioequivalent and therapeutically equivalent generic to the reference listed drug atropine sulfate injection, USP, 0.5 mg/5 mL in a prefilled single-dose syringe.

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