ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for nilutamide tablets which is first generic competitor to Nilandron®. Trailing twelve- month sales of Nilandron® were $23 million according to IMS Health.
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.
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, fenofibrate50mg and 150mg capsules, oxycodone 5mg capsules, and hydroxyprogesterone caproate injection USP 250mg/mL.”
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