(By Balaseshan) Perrigo Co. (NASDAQ:PRGO) said it has received U.S. regulatory authorities approval and began launch of morphine sulfate oral solution to relieve acute and chronic pain where use of an opioid analgesic is appropriate.
The Allegan, Michigan-based company has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for morphine sulfate 100ml/5% oral solution. Perrigo will commence shipment of the product immediately.
"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," said Joseph Papa, Chief Executive of Perrigo.
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 about $26 million, as measured by Wolters Kluwer Health.
Previously on June 27, Perrigo received final approval from the U.S. regulatory authorities for its ANDA for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac Gel, which is indicated for the topical treatment of inflammatory acne vulgaris.
On June 6, Perrigo received final approval from the U.S. regulatory authorities for its ANDA for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps, which are indicated for hyperphosphatemia in end stage kidney dialysis patients.
PRGO is trading up 0.35% at $115.42 on Wednesday. The stock has been trading between $77.54 and $119.29 for the past 52 weeks.