Mylan receives final FDA approval for Morphine Sulfate ER Tablets ANDA

Oct 27 2011

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 Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the generic version of Purdue Pharma's MS Contin^®, an opioid analgesic for moderate to severe pain management.  

Morphine Sulfate ER Tablets had U.S. sales of approximately $173 million for the 12 months ending June 30, 2011, according to IMS Health. Mylan is launching this product immediately.

Currently, Mylan has 163 ANDAs pending FDA approval representing $97.5 billion in annual sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.