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news.Mylan Pharmaceuticals, a subsidiary of Mylan, has received final approval from FDA for its abbreviated new drug application (ANDA) for Ibandronate Sodium Tablets, 150mg and initiated the product shipment.
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The product, a generic equivalent to Roche’s Boniva, is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Boniva had US sales of approximately $517m for the 12 months ending 31 December 2011 and currently Mylan has 173 ANDAs pending FDA approval representing $100.9bn in annual sales.
Mylan is a generic and specialty pharmaceutical company and provides products to customers in more than 150 countries and territories.