ANI Pharma Announces FDA Approval And Immediate Launch Of Nilutamide Tablets

(RTTNews) - ANI Pharmaceuticals Inc. (ANIP) announced that it has received approval from the U.S. Food and Drug Administration of the Abbreviated New Drug Application or "ANDA" for nilutamide tablets. Trailing twelve-month sales of Nilandron were $23 million according to IMS Health. ANI will immediately launch the product.

Nilutamide tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).

For maximum benefit, nilutamide treatment must begin on the same day as or on the day after surgical castration.