ALLEGAN — The Allegan-based health and beauty products manufacturer Perrigo Co. (Nasdaq: PRGO) said Wednesday it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for morphine sulfate 100ml/5 percent 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.
“This approval is a testament to our continued commitment to bring new specialized products to market,” said Perrigo chairman and CEO Joseph C. Papa. “We continue to focus on our mission of making healthcare more accessible and affordable for consumers.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. Perrigo’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.