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Hong Kong firm petitions FDA on acetaminophen equivalency

This article was originally published in The Tan Sheet

Executive Summary

Wishing to bring its "effective, safe but cheap drug to U.S. patients," Bright Future Pharmaceutical Lab Ltd. asks FDA to allow the use of GlaxoSmithKline's 500-mg acetaminophen drug Panadol as the reference listed drug in an abbreviated new drug application for the Hong Kong firm's BF-PARADAC. Although the Orange Book contains no RLD identical to BF-PARADAC in dosage form, strength or formulation, Panadol is pharmaceutically and/or therapeutically equivalent to Bright Future's drug, the company says in its ANDA suitability 1petition dated Dec. 17. Bright Future says the bioequivalence study of BF-PARADAC using Panadol as the reference is complete, and asks FDA to suggest another RLD equivalent to its drug

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