Mylan Announces Final FDA Approval For Finasteride Tablets USP, 5mg

Main Category: Men's health
Also Included In: Prostate / Prostate Cancer
Article Date: 20 Dec 2006 - 0:00 PDT

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Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Finasteride Tablets USP, 5mg.

The Mylan brand of Finasteride Tablets, a generic version of Merck's Proscar(R) Tablets, is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) 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 U.S. sales for the 5mg strength of Finasteride Tablets was approximately $553 million for the 12-month period ended Sept. 30, 2006, according to data from IMS Health.

This product will be shipped immediately.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

For more information about Mylan, please visit http://www.mylan.com.

Mylan Laboratories Inc.
http://www.mylan.com