Mylan (MYL) Unit Launches Generic Detrol Tabs
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Mylan, Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tolterodine Tartrate Tablets, 1 mg and 2 mg. This product is the generic version of Pharmacia and Upjohn's Detrol® Tablets and is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Tolterodine Tartrate Tablets USP, 1 mg and 2 mg, had U.S. sales of approximately $61.5 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 174 ANDAs pending FDA approval representing $79.5 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
Tolterodine Tartrate Tablets USP, 1 mg and 2 mg, had U.S. sales of approximately $61.5 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 174 ANDAs pending FDA approval representing $79.5 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
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