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Zydus gets FDA ok for bromocriptine mesylate

This article was originally published in Scrip

Executive Summary

Zydus Cadilahas received US FDAapproval to market bromocriptine mesylate capsules 5mg, a generic version of Novartis's Parlodel capsules. Bromocriptine mesylate capsules are used for the treatment of hyperprolactinaemia-associated dysfunctions, acromegaly, and Parkinson's disease. Sales of bromocriptine mesylate capsules were estimated at $11.4 million in 2007. Zydus now has 40 ANDA approvals and has filed 79 ANDAs with the FDA.



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