Mylan Inc. (Nasdaq: MYL) today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Risedronate Sodium Tablets USP, 150 mg, had U.S. sales of approximately $171.6 million for the 12 months ending March 31, 2014, according to IMS Health.
Currently, Mylan has 303 ANDAs pending FDA approval representing $105.3 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.