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ANI Gets FDA Approval For First Generic Competitor to Nilandron

Announces immediate launch of nilutamide tablets

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By: Tim Wright

Editor-in-Chief, Contract Pharma

ANI Pharmaceuticals has received approval from the FDA for the abbreviated new drug application (ANDA) for nilutamide tablets, the first generic competiro to Nilandron. Trailing twelve-month sales of Nilandron were $23 million according to IMS Health. ANI will immediately launch the product. “The nilutamide approval exemplifies ANI’s strategic focus to introduce high barrier niche generic products,” said Arthur Przybyl, president and chief executive officer, ANI. “We are excited t...

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