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Zantac 75

This article was originally published in The Tan Sheet

Executive Summary

Exclusivity extended six months to June 19 from Dec. 19 upon FDA acceptance of pediatric data submitted for the drug by Glaxo Wellcome. The company sent data to the agency Dec. 18 regarding neonatal injection of the molecule ("The Tan Sheet" Jan. 4, p. 4). In a Jan. 11 letter, FDA denies Novopharm's Nov. 9 citizen petition seeking to bar the six-month extension ("The Tan Sheet" Dec. 7, 1998, p. 18). In its response, the agency says the "plain language of the [FDA Modernization] Act is consistent with the legislative intent of the act to offer pediatric exclusivity as an incentive to obtain pediatric studies on all drugs, including OTC drugs." Novopharm was granted tentative approval of its ANDA for ranitidine 75 mg tablets Jan. 22, along with 180 days of generic exclusivity from the date of first commercial marketing (see related story, p. 21)

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