ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, February 13, 1996 TAG: 9602130113
SECTION: NATIONAL/INTERNATIONAL PAGE: A5 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: ASSOCIATED PRESS
PHARMACIA & UPJOHN OFFICIALS SAID they will market nonprescription Rogaine for $29.50 for a month's supply.
Balding Americans will be able to buy the hair-growth drug Rogaine by spring without stopping to see a doctor first.
The Food and Drug Administration decided Monday that Rogaine can be sold in drugstores alongside shampoos and hair colorings, making it the only medically proven drug to fight baldness available without a prescription.
But while the move means people can buy a little hope against hair loss for about $30 a month, the FDA warned that not everybody should.
Some 40 million men and 20 million women suffer hair loss, most the hereditary form commonly known as male-pattern balding. This is the only hair loss helped by Rogaine, which has been sold by prescription since 1988.
Even for those people, however, Rogaine doesn't always work, said FDA spokeswoman Ivy Kupec. It helps about 25 percent of men and 20 percent of women to very gradually grow back moderate amounts of hair, mostly on the very top of the head.
They must keep using Rogaine indefinitely to keep the new hair.
``We recommend people try it for four months, but we actually had people in clinical studies who took longer than that,'' said Dr. Joann Data of manufacturer Pharmacia & Upjohn.
People should try Rogaine only if hair loss runs in their family and isn't a sudden or patchy type that might come from an endocrine imbalance, infection, pregnancy or even such hairstyles as tight braids, Data said.
Pharmacia & Upjohn said it will sell nonprescription Rogaine for $29.50 for a month's supply, about half the price of the identical prescription version.
Sales will begin in April with packages formulated as Rogaine for Men and Rogaine for Women to provide gender-based instructions and illustrations that show whether using Rogaine is appropriate and how to apply it to the scalp.
The FDA's decision comes at a vital time for the Kalamazoo, Mich.-based company. The patent on Rogaine, with annual U.S. sales totaling $96 million, expires today, and a generic manufacturer was poised to begin selling a competitor. Pharmacia asked the FDA Monday for three extra years of marketing exclusivity, under a little-known law that gives such a bonus when companies do extra research to prove a prescription product is safe to use over the counter. The FDA has not made a decision.
Side effects are mainly skin irritation and itching. But people should see a doctor if they develop chest pain, rapid heart beat, faintness, weight gain or swollen hands or feet, Kupec said.
LENGTH: Medium: 54 linesby CNB