Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Jan 7 2014

Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Tolterodine Tartrate Extended-release (ER) Capsules, 2 mg and 4 mg. Tolterodine Tartrate ER Capsules are the generic version of Pfizer's Detrol® LA, and are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Tolterodine Tartrate ER Capsules had U.S. sales of approximately $571.5 million for the 12 months ending Sept. 30, 2013, according to IMS Health.

Currently, Mylan has 188 ANDAs pending FDA approval representing $94 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.

SOURCE Mylan Inc.