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Back To Vidyya FDA Puts Hold On Generic Form of Pepcid®

Preservation Of Market Exclusivity is Granted On Basis of Pediatric Studies

Merck announced today that the Food and Drug Administration has granted an additional six months of U.S. marketing exclusivity to Pepcid® (famotidine) in response to a supplemental new drug application (sNDA) the Company filed on pediatric studies.

This six-month marketing exclusivity will delay FDA approval of any generic famotidine until midnight EST April 15, 2001.

Under provisions of the FDA Modernization Act of 1997 (FDAMA), a pharmaceutical company can obtain an additional six months of marketing exclusivity for a drug if the company, in accordance with the requirements of the statute, conducts acceptable studies of that drug in children. This incentive was included in FDAMA to encourage pharmaceutical companies to conduct studies of drugs for which additional pediatric information may produce health benefits in children.

Merck submitted the sNDA on Aug. 28, 2000, in response to a Written Request from the FDA seeking pediatric studies. The granting of extended marketing exclusivity represents a determination by the FDA that Merck has fulfilled the terms of the Written Request. The study data submitted in the sNDA are still under review by the FDA. As the review is ongoing, there has been no change to the prescribing information for Pepcid.

Pepcid is a prescription drug indicated for the short-term treatment of acid reflux and stomach ulcers and the treatment of abnormally high levels of stomach acid. Pepcid is generally well tolerated, but is not for everyone. The most common side effects of Pepcid are headache, dizziness, constipation and diarrhea.

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Editor: Susan K. Boyer, RN
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