The US Food and Drug Administration (FDA) has granted final approval for Perrigo Company's abbreviated new drug application (ANDA) for morphine sulfate 100ml/5 per cent 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.

Perrigo’s chairman, president and CEO Joseph C Papa stated, “This approval is a testament to our continued commitment to bring new specialized products to market. We continue to focus on our mission of making healthcare more accessible and affordable for consumers.”

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API).