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FDA has approved Propecia for hair loss, making it the first such treatment for men in pill form. The following can be used to answer questions:

The active ingredient in Propecia is finasteride. Finasteride was approved initially in 1992 as Proscar, a treatment for prostate enlargement. There is 1 mg of finasteride in Propecia and 5 mg in Proscar. It was observed that some patients being treated for prostate enlargement had some regrowth of hair in areas of male pattern hair loss.

The sponsor studied 1 mg of finasteride and demonstrated hair growth in male pattern hair loss. The number of hairs increased in the anterior midscalp and vertex. Patient self-assessment of hair growth was also superior to placebo. Side effects were infrequent and were related to sexual function.

The drug will not be marketed for women because it causes birth defects, and the safety and efficacy have not been established in women.

Recently, FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee discussed Propecia. The committee offered labeling suggestions in the context of an overall generally favorable discussion. Merck & Co. of West Point, Pa.,manufactures both Proscar and Propecia.

http://www.fda.gov/bbs/topics/ANSWERS/ANS00842.html

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

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