Aurobindo Pharma receives USFDA final approval for Fluoxetine tablets

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fluoxetine Tablets, 10 mg and 20 mg. Fluoxetine tablets are generic version of Eli Lilly's Prozac tablets. The product will be launched in April 2020.

This is the 1st ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India, used for manufacturing oral products. Aurobindo now has a total of 424 ANDA approvals (396 Final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

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