ANI Pharma: FDA Approves ANDA For Fluoxetine Oral Solution

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

ANI's Fluoxetine Oral Solution is the generic version of the Reference Listed Drug or RLD Prozac. According to IQVIA/IMS Health, a healthcare data and analytics provider, Fluoxetine Oral Solution's current annual U.S. market is around $14.6 million.

Nikhil Lalwani, President and Chief Executive Officer of ANI, said, "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."