Roxane Labs' generic prostate drug gets tentative approval from FDA

FDA grants preliminary approval to generic dutasteride capsules

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

The FDA granted tentative approval to Roxane Labs' dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK's Avodart, used to treat benign prostatic hyperplasia.

Tentative approval means that a drug meets the agency's conditions for approval, but can't receive final approval until Avodart loses its patent protection, which will occur in 2015.


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