Perrigo Receives FDA Approval for Calcium Acetate Capsules
ALLEGAN — Perrigo Co. (Nasdaq: PRGO) announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps.
Perrigo was previously in patent litigation over this product with the brand and the litigation settled in late 2011. The terms of the settlement are confidential.
Phoslo Gelcaps (calcium acetate) are indicated for hyperphosphatemia in patients with end stage kidney disease who are on dialysis. Phoslo Gelcaps annual brand and equivalent generics sales were approximately $95 million, as measured by Wolters Kluwer Health.
“This product is another example of Perrigo’s commitment to expand our portfolio and bring new products to market,” said Perrigo chairman, president and CEO Joseph C. Papa. “This is another demonstration of our strategy to provide more affordable, high quality healthcare products to patients.”
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. The company’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.