Mylan Inc arm gets US OK for Tolterodine tartrate tablets
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Mylan Inc said its arm Mylan Pharmaceuticals Inc has secured final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Tolterodine tartrate tablets of 1 mg and 2 mg respectively.
This product is the generic version of Pharmacia and Upjohn’s Detrol® Tablets. It is indicated for treating overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Tolterodine tartrate tablets had U.S. sales of approximately $61.5 million for 12 months ending September 30, 2012 as per IMS Health.
Thirty six of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales for 12 months ending June 30, 2012.
Mylan is a global pharmaceutical company that offers portfolio of more than 1,100 generic pharmaceutical and several brand medications. It also offers a wide range of antiretroviral therapies, on which about one-third of HIV/AIDS patients in developing countries depend. It also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 150 countries and territories.
The company has a workforce of over 18,000 people and is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world.
It also operates a fully integrated specialty pharmaceuticals business, Mylan Specialty, which produces innovative medicinal therapies including EpiPen® auto-injector.