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FDA approves first generic nilutamide for treatment of prostate cancer Posted 12/08/2016

US generics producer ANI Pharmaceuticals (ANI) announced on 18 July 2016 that it had received US Food and Drug Administration (FDA) approval for its generic version of prostate cancer treatment Nilandron (nilutamide).

ANI is a US-based specialty pharmaceuticals company that develops, manufactures and markets prescription pharmaceuticals, including both brand-name and generic drugs, with a focus on cancer treatments, hormones and pain relievers. The company acquired over 20 previously marketed generics from Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, in July 2015 [1].

Nilutamide is used in combination with surgery for treatment of advanced prostate cancer – the second most common type of cancer worldwide, affecting over one million men in 2012 alone. The synthetic compound can slow the progression of this aggressive cancer and extend life for its sufferers. This is the first generic version of the compound, which was previously marketed in the US as Nilandron.

According to ANI’s President and CEO Arthur Przybyl, the approval is in line with the company’s efforts to introduce ‘high barrier, niche generic products’. Nilutamide will be the second anticancer therapeutic on ANI’s books, which will be produced at their specialized manufacturing plant in Minnesota, USA.

The product will be launched immediately, and follows a string of new product launches at ANI, including propranolol (a beta blocker), fenofibrate (used to lower cholesterol levels), hydroxyprogesterone caproate (a hormonal therapy used to prevent preterm birth and treat endometrial cancer) and pain relief medication oxycodone.

The company said the product launches were thanks to internal product development, acquisitions and partnered distribution and reflect strategic efforts to expand its product line.

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1. GaBI Online - Generics and Biosimilars Initiative. ANI Pharmaceuticals acquires 22 generics from Teva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from: http://www.gabionline.net/Generics/News/ANI-Pharmaceuticals-acquires-22-generics-from-Teva

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Source: ANI Pharmaceuticals, IARC

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