Pharma Focus Asia

ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP

Tuesday, November 29, 2022

ANI Pharmaceuticals, Inc., announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg/5 mL.

ANI’s Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac®. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We continue to strengthen our generics business with new product launches, and laud the efforts of our R&D team in helping the Company fulfill its ongoing commitment to provide affordable generic alternatives to customers and patients in need,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

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