FDA APPROVES FINASTERIDE TO TREAT MALE PATTERN HAIR LOSS IN MEN

[FDA]

FDA
TALK PAPER

_Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857_
_________________________________________________________________

_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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Ivy Fleischer Kupec: 301-827-6242
T97-66 Broadcast Media: 301-827-3434
December 22, 1997 Consumer Inquiries: 800-532-4440

FDA APPROVES FINASTERIDE TO TREAT MALE PATTERN HAIR LOSS IN MEN

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.