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Perrigo announces FDA final approval for generic version of nitrolingual spray

Perrigo 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 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 $65M.