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news.Mylan Pharmaceuticals has won USFDA approval for its abbreviated new drug application (ANDA) for Meclizine Hydrochloride Tablets USP, 12.5mg, 25mg and 50mg.
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The company has announced immediate shipment of the product.
The generic version of Pfizer’s Antivert is indicated for the management of nausea and vomiting, and dizziness associated with motion sickness.
According to IMS Health, for the 12 months ending 30 June 2012, Antivert Tablets, 12.5mg, 25mg and 50mg, had US sales of $53.5m.
At present, Mylan’s 169 ANDAs, which represent $79.4bn in annual sales, are yet to receive FDA approval.