UPDATE: Perrigo Wins FDA Approval for Generic Version of Nitrolingual Spray
Perrigo Company (NYSE: PRGO) today 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 as 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 indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease and has estimated annual sales of approximately $65 million.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval once again exemplifies how our research and development capabilities in extended topicals translate into first to market new product approvals. 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, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and