ANI Pharmaceuticals Gets FDA Approval and Immediate Launch of Nilutamide Tablets

ANI Pharmaceuticals, Inc.

revealed that it received the FDA approval for its Abbreviated New Drug Application ("ANDA") for nilutamide tablets. According to the company, IMS Health data pointed out a revenue of $23 million for trailing twelve-month period from the sales of Nilandron. The company also launch the product immediately. ANI Pharmaceuticals' President and CEO, Arthur Przybyl, commented, "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 company indicated that the nilutamide launch was its eighth new product since the commencement of the second quarter of the current year. The earlier launches included 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. ANI said that the product launches were the direct result of internal product development, acquisitions and partnered distribution. It also represented the combined strategic approach to its product line expansion. On Monday, the stock advanced 0.69 percent at the time of writing this.