Answers
04/28/1995

<TITLE>FAMOTIDINE APPROVED AS OVER-THE-COUNTER HEARTBURN MEDICATION</TITLE>
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T95-21                                                   Ivy F. Kupec
April 28, 1995                                           (301) 443-3285

    FAMOTIDINE APPROVED AS OVER-THE-COUNTER HEARTBURN MEDICATION

        The Food and Drug Administration today announced approval of famotidine
(Pepcid AC Acid Controller) for over-the-counter marketing to treat and prevent
episodic heartburn.  It has been available by prescription since 1986 to treat 
ulcers and other gastrointestinal illnesses.  Polls indicate that 40 percent of 
people in the United States suffer from heartburn. 
        Pepcid AC Acid Controller is the first drug of its class to be granted 
over-the-counter status.  Antacids are also used to treat heartburn; they work 
in the stomach to neutralize stomach acid.  Pepcid AC Acid Controller works 
systemically to reduce the amount of stomach acid produced.  In clinical studies,
Pepcid AC was shown to be up to 28 percent more effective than a placebo in
relieving heartburn when taken after the heartburn developed, and up to 21 
percent better in preventing it when taken one hour before a meal.
        Pepcid AC Acid Controller will be marketed in 10 mg tablets of
famotidine to relieve symptoms of occasional heartburn, acid indigestion and
sour stomach in people age 16 and older.  It may also be taken one hour before 
consuming food and beverages expected to cause these symptoms in order to 
prevent or reduce them.  
        No more than two tablets should be taken in 24 hours.  Consumers should
see a doctor if they have trouble swallowing or suffer persistent abdominal pain,
as these symptoms may indicate a more serious condition.     
        The product will be distributed by Johnson & Johnson/Merck Consumer
Pharmaceuticals Co. of Fort Washington, Pa.
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