Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

A Pill for Male Pattern Baldness Wins Approval From the F.D.A.


April 12th, 2008 by admin


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For as long as there has been baldness, it seems, there have been efforts to cure it: oils and creams, toupees and transplants, not to mention what hair stylists gingerly term ”the comb-over.” But as much as some men may have wanted one, there has never been a baldness pill — until now.

The Food and Drug Administration announced today that it had given Merck & Company, the maker of crucial treatments for heart disease, osteoporosis and AIDS, permission to sell a tiny tan octagonal tablet that, experiments show, either promoted the growth of hair or at least stopped hair loss in 83 percent of men who took it.

There are, however, some drawbacks: The pill, which will be marketed as a prescription medicine under the brand name Propecia, can cause birth defects and so is not approved for women. It is useful only for the genetic condition known as male pattern baldness. It must be taken once a day, every day, for the rest of a bald man’s life. And it carries a slight risk of impotence, lasting as long as it is taken.

”This is not a panacea,” said Dr. E. William Frank, a dermatologist at Beth Israel Deaconess Medical Center in Boston who has been following the progress of the drug during testing. ”It’s not going to grow hair on the pate of every man who takes it. But the clinical studies which have been done so far are promising.”

Critics say the idea of a prescription drug for baldness is frivolous, and complain that no long-term studies have been conducted on the drug.

”It is a cosmetic issue,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, an advocacy organization in Washington. ”What is the risk that we are trading off for a cosmetic benefit?”

And John T. Capps 3d, founder of Bald-Headed Men of America, a support group for bald men, said no right-thinking bald man would even consider a pill.

”We believe that skin is in,” Mr. Capps said.

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