THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Saturday, April 29, 1995 TAG: 9504290371
SECTION: FRONT PAGE: A5 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Short : 43 lines
Pepcid, a powerful ulcer drug, has been cleared for over-the-counter sales for heartburn, the Food and Drug Administration said Friday.
It is the first drug of its class - H2 antagonists - to win government approval to be sold without a prescription.
Unlike antacids, which fight heartburn by neutralizing stomach acid, Pepcid can reduce the amount of acid the stomach produces. It is similar to another top-selling ulcer drug, Tagamet, that the FDA also is considering converting from prescription to over-the-counter status.
The remedy called Pepcid AC Acid Controller is being jointly marketed by Johnson & Johnson and Merck Consumer Pharmaceuticals Co.
Millions of Americans suffer from heartburn, and they spend millions of dollars on remedies for the painful problem.
Pepcid has been sold by prescription since 1986 to treat ulcers and other gastrointestinal illnesses.
The FDA said that in clinical studies, Pepcid - known generically as famotidine - was up to 28 percent more effective than an unmedicated placebo in relieving heartburn after the symptom developed, and up to 21 percent better in preventing it when taken an hour before a meal.
The over-the-counter version of Pepcid is half the strength of the usual prescription dosage.
Betsy Adams, an FDA spokeswoman, said the agency emphasized that if people have trouble swallowing or suffer persistent abdominal pain, they should see a doctor.
Merck spokesman Gary Lachow said its sale price hasn't yet been set, but it will be similar to existing antacids. As a prescription drug, Pepcid now retails for about $88 for a bottle of 50, but over-the-counter drugs usually cost much less than their prescription-only predecessors.
Company officials said the drug would be in stores next month. by CNB