FDA Committee Gives Nod To Glaxo's OTC Zantac

A US Food and Drug Administration advisory committee has recommended approval for an over-the-counter version of Glaxo's antiulcerant Zantac (ranitidine). When finally approved by the agency, it will be the third H2 antagonist switch product to join the market, where it will compete with SmithKline Beecham's Tagamet (cimetidine) and Merck's Pepcid (famotidine). OTC Zantac is already sold in the UK, through the Warner-Wellcome OTC marketing venture set up last year.

Michael Weintraub, director of the FDA's office of over-the-counter drug evaluation, said some members of the two advisory committees which gave their approval to the switch wanted to allow Zantac to be taken three time a day, rather than the two per day limit already allowed for Pepcid and Tagamet, in case a person had a particularly severe attack. However, Glaxo did not request such dosing, and the move to allow it failed on a 12 to 4 vote.

Contrary to the expectation of some doctors, the committees are not recommending that Glaxo puts warnings against drug interactions on the label for the OTC version of Zantac. Tagamet's label does include such a warning, because in rare cases the drug has been shown to alter the effects of warfarin, theophylline and phenytoin. Glaxo presented data showing that at the OTC and at higher does Zantac does not have the same drug interactions, Dr Weintraub said. It was noted that the FDA could overrule the advisory committees and require warnings; it allowed Pepcid on the market without them.