Perrigo Co. (PRGO) said it has received final approval from the FDA for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will commence shipment of the product immediately.
Morphine sulfate oral solution, a Schedule II controlled substance, is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Generic annual sales were approximately $26 million, as measured by Wolters Kluwer Health.
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