Perrigo Announces FDA Final Approval For Generic Version Of Nitrolingual Spray
ALLEGAN (WWJ) — Perrigo Co. (NYSE: PRGO) announced that it has received final approval for its abbreviated new drug application for nitroglycerin lingual spray, 400 mcg/spray, the generic equivalent to Nitrolingual Pumpspray.
Perrigo was awarded 180 days of generic drug exclusivity because it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo has commenced shipment of the product.
Nitrolingual Pumpspray (nitroglycerin lingual spray, 400 mcg/spray) is taken to relief angina pectoris, sharp chest pain caused by exertion in people with coronary artery disease. It has estimated annual sales of $65 million.
“This approval once again exemplifies how our research and development capabilities in extended topicals translate into first to market new product approvals,” said Perrigo chairman, president and CEO Joseph C. Papa. “Perrigo is committed to developing complex products and making quality healthcare more affordable for consumers around the world.”
From its beginnings as a packager of generic home remedies in 1887, Allegan-based Perrigo Company has grown to become the world’s largest manufacturer of over-the-counter pharmaceutical products for the store brand market. Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients. Its major markets are the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at http://www.perrigo.com.