PITTSBURGH — Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.
Mylan said its abbreviated new drug application for morphine sulfate extended-release tablets in the 15-mg, 30-mg, 60-mg, 100-mg and 200-mg strengths was approved by the FDA. The opioid analgesic is a generic version of Purdue Pharma's MS Contin. Mylan said it is launching the product immediately.
Morphine sulfate ER tablets had U.S. sales of approximately $173 million for the 12 months ended in June, according to IMS Health.