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Pediatric ExclusivitySection 111 of Title I of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), signed into law by President Clinton on November 21, 1997, created section 505A of the Federal Food, Drug and Cosmetic Act (the Act) (U.S.C. 355a). Section 505A permits certain applications to obtain an additional six months of marketing exclusivity (pediatric exclusivity) if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. The following links are provided to assist generic drug applicants in determining whether a drug product might be or is subject to pediatric exclusivity.
Date created: November 1, 1998; last update: July 7, 2005 |
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