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news.Generic drug maker Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for prostate treatment finasteride tablets at 5mg strength.
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The Mylan brand of finasteride, a generic version of Merck’s Proscar, is approved for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to improve symptoms and reduce the risk of the need for surgery including transurethral resection of the prostate and prostatectomy.
Total US sales for the 5mg strength of Finasteride Tablets were approximately $553 million for the 12-month period ended September 30, 2006, according to data from IMS Health.
Mylan said the product would be shipped immediately.