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