ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP
ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today 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
BAUDETTE, Minn.--(BUSINESS WIRE)--Nov 28, 2022--
ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today 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.
