Mylan Pharmaceuticals Inc., a US subsidiary of Mylan 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 US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
According to IMS Health, tolterodine tartrate ER capsules had US sales of approximately $571.5 million for the 12 months ending September 30, 2013.
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.
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