Mylan Receives Approval for Generic Version of Precose® Tablets

Mylan Receives Approval for Generic Version of Precose® Tablets


PITTSBURGH, Jan. 18, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Acarbose Tablets had U.S. sales of approximately $23 million for the 12 months ending Sept. 30, 2010, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 169 ANDAs pending FDA approval representing $99.5 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.

SOURCE Mylan Inc.


News Provided by Acquire Media

 

Suggested Articles

After Purdue’s record opioid settlement, more deals could be on the way. But that doesn’t mean all defendants are prepared to go quietly.

Now in their third quarter on the market, Gilead's own Epclusa and Harvoni generics have together grabbed more than 20% of the U.S. hep C market.

Purdue is seeking bankruptcy after inking a $10 billion-plus opioid settlement with thousands of cities and counties, plus two dozen states.