Pharmaceutical company Impax Laboratories (NasdaqGS:IPXL) revealed on Tuesday the receipt of the final approval from the US Food and Drug Administration for the generic version of dutasteride capsules, 0.5 mg.

On 20 November 2015, the US FDA approval was awarded to the company's development and manufacturing partner.

Following the US FDA approval, the company has initiated commercialisation activities through its generic division.

This is reportedly the 13th generic product launched in 2015 by the company's generic division.

For the 12 months ending in September 2015, US brand and generic sales of dutasteride capsules, 0.5 mg were about USD457m, according to IMS Health (NSP).