ANI Pharma launches first generic nilutamide on FDA approval

18 July 2016

US generic drugmaker ANI Pharmaceuticals (Nasdaq: ANIP) today revealed that it has received approval from the US Food and Drug Administration of the Abbreviated New Drug Application for nilutamide tablets.

Trailing 12-month sales of Nilandron (nilutamide) were $23 million, according to IMS Health figures quoted by ANI, which also said it will immediately launch the product.

In 2013, French pharma major Sanofi (Euronext: SAN) sold Swiss specialty drug firm Covis Pharma full commercial rights to a batch of drug brands, including Nilandron.

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