28 November 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 Fluoxetine Oral Solution, USP 20 mg/5 mL, the company said.

ANI's Fluoxetine Oral Solution is the generic version of the Reference Listed Drug Prozac.

The current annual US market for Fluoxetine Oral Solution is approximately USD 14.6m, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

ANI Pharmaceuticals is a bio-pharmaceutical company engaged in developing, manufacturing, and marketing high quality 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 our North American manufacturing capabilities.