ANI Pharmaceuticals Receives FDA Approval of, Plans Imminent Launch of Clorazepate Dipotassium Tablets USP
23 June 2022 - - US-based biopharmaceutical company ANI Pharmaceuticals, Inc (NASDAQ: ANIP) has received US Food and Drug Administration approval for the Abbreviated New Drug Application for Clorazepate Dipotassium Tablets, the company said.

ANI's Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug Tranxene.

The current annual US market for Clorazepate Dipotassium Tablets is approximately USD 25.8m, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

ANI Pharmaceuticals is engaged in developing, manufacturing, and marketing branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

Its team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging its North American manufacturing capabilities.