Mylan announces tentative approval for Finasteride tablets

By Elaine Rigoli

Tampa, Fla., April 18 - Mylan Laboratories, Inc. announced Tuesday that the Food and Drug Administration has granted tentative approval for its abbreviated New Drug Application for Finasteride tablets USP, 5 mg.

Finasteride tablets are the AB-rated generic equivalent of Merck's Proscar tablets, 5 mg, which had annual U.S. sales of about $390 million as of Dec. 31, the company said in a news release.

Finasteride is used to treat benign prostatic hypertrophy, which sometimes occurs in men over 55 years of age and causes the prostate gland to enlarge.

Based in Pittsburgh, Mylan Laboratories develops, licenses, manufactures, markets and distributes generic and proprietary products.

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