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Ranbaxy Of India U.S. FDA Problems Cited In U.S. Generics Challenges

This article was originally published in PharmAsia News

Executive Summary

India's Ranbaxy Laboratories and its recent problems with the U.S. FDA have been cited by a Canadian drug maker as further evidence against Ranbaxy in a court challenge to two of its generics. Canada's Apotex has sued in a U.S. court to block Ranbaxy from entering the generics market for two major drugs, GlaxoSmithKline's Valtrex (valacyclovir) herpes drug and Eisai's Aricept (donepezil) for Alzheimer's disease. As the first generic filer, Ranbaxy would have six months of exclusivity with a Valtrex generic, beginning immediately, and also with Aricept once its patent expires. Apotex cited FDA warning letters against Ranbaxy manufacturing plants as reasons to deny its generics. (Click here for more



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