The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules.
The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage kidney disease who are on dialysis.
Perrigo chairman, president and CEO Joseph Papa said, "This is another demonstration of our strategy to provide more affordable, high quality healthcare products to patients."
The company was previously in patent litigation over the product with the brand, which was settled in late 2011.
Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-clears-perrigo-anda-for-calcium-acetate-capsules-070612
