The US Food and Drug Administration (FDA) has approved ANI Pharmaceuticals' Abbreviated New Drug Application (ANDA) for nilutamide tablets. Trailing twelve-month sales of nilandron were $23 million according to IMS Health. ANI will immediately launch the product.
Arthur S Przybyl, ANI’s president and CEO stated, “The nilutamide approval exemplifies ANI’s strategic focus to introduce high barrier niche generic products. We are excited to have secured approval for a first-to-market generic that represents ANI’s second entry into the anti-cancer market and leverages our specialized high-potent manufacturing capability at our plant in Baudette, MN.
“The nilutamide launch is ANI’s eighth new product launch since the beginning of the second quarter of 2016. The previously-announced launches were hydrocortisone rectal cream 1% and 2.5%, Inderal LA capsules, propranolol ER capsules, mesalamine enema, fenofibrate 50mg and 150mg capsules, oxycodone 5mg capsules, and hydroxyprogesterone caproate injection USP 250mg/ml. The launches are the direct result of internal product development, acquisitions and partnered distribution and represent the combined strategic approach to ANI’s product line expansion.”
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.