ANI obtains FDA nod for generic Prozac
ANI has received the Food and Drug Administration’s clearance for fluoxetine oral solution, 20 mg/5 ml, which is the generic of Eli Lilly's Prozac.
The medication treats depression, panic attacks, obsessive-compulsive disorder, bulimia and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).
Fluoxetine oral solution has a market value of approximately $14.6 million, according to IQVIA.
[Read more: FDA gives ANI green light for Cortrophin Gel]
“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,” said Nikhil Lalwani, president and CEO of ANI.