FDA Advisory Panels Recommend Against Non-Prescription Tagamet

From Reuters

SmithKline Beecham PLC was dealt a second setback Thursday in its quest for regulatory approval to sell its prescription ulcer drug Tagamet as an over-the-counter heartburn remedy.

Two advisory panels to the Food and Drug Administration recommended against approving the drug for over-the-counter sale, saying they were concerned about its reaction with other drugs patients might be taking.

The advisers said, however, that a mild version of Tagamet could be recommended for sale for heartburn if the company can resolve these concerns.


The FDA usually follows the recommendations of its advisory committees, but it is not bound by them.

“We’re not surprised by the outcome. Our key objective going into the meeting was to resolve the issue of efficacy, and the committee agreed ‘Yes, there is efficacy,’ ” a spokeswoman for the British drug company said in London. “We’re very comfortable that we will be able to work directly with the FDA to resolve any outstanding issues,” she said.

The two FDA panels had rec- ommended against over-the-counter Tagamet sales last September, saying tests did not show it was effective for episodic heartburn.

An over-the-counter version of Tagamet has been approved in other countries.

Tagamet was once a $1-billion drug for the company, but its sales have fallen since May, when it lost its patent protection.

SmithKline Beecham shares, traded as American Depository Receipts, closed off 37.5 cents at $31.375 on the New York Stock Exchange.