Perrigo Company, a healthcare company, has won final FDA approval for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution.
Perrigo will immediately begin the shipment of Morphine sulfate oral solution, a Schedule II controlled substance.
Morphine sulfate oral solution is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
Perrigo chairman, president and CEO Joseph Papa said, "This approval is a testament to our continued commitment to bring new specialized products to market."
The generic annual sales of the product as measured by Wolters Kluwer Health, were approximately $26m.
Perrigo Company develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients.