#abbreviated new drug application#treating overactive bladde

Mylan Inc arm gets US OK for Tolterodine tartrate tablets

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 app...

Admin
|Nov 30|magazine4 min read

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.