ALLEGAN, Mich. — Perrigo Co. has received final approval from the Food and Drug Administration for its abbreviated new drug application (ANDA) for morphine sulfate 100ml/5% oral solution.
The company said Wednesday that it will start shipping the product, a narcotic pain medication, immediately.
Morphine sulfate oral solution is a Schedule II controlled substance, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
Generic annual sales of the medication are approximately $26 million, according to Wolters Kluwer Health data cited by Perrigo.
