ANI Pharmaceuticals receives FDA approval for Fluoxetine Oral Solution USP
28 November 2022 -

Bio-pharmaceutical company ANI Pharmaceuticals Inc (ANI) (Nasdaq: ANIP) revealed on Monday that the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20mg/5mL has received U.S. Food and Drug Administration (FDA) approval,

The company said that Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac.

According to healthcare data and analytics provider IQVIA/IMS Health, the current annual US market for Fluoxetine Oral Solution is approximately USD14.6m, ANI stated.

ANI develops, manufactures and markets high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical needs.