Mylan Inc's subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for tolterodine tartrate tablets, one mg and two 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 US 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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