Mylan Receives Approval for Generic Version of MS Contin Tablets
Mylan has received FDA approval for its Abbreviated New Drug Application for Morphine Sulfate Extended-release (ER) Tablets.
Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received FDA approval 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 product is 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
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