ALLEGAN, Mich. — Perrigo Co. has received Food and Drug Administration approval for nitroglycerin lingual spray (400 mcg/spray).
The company said Monday that it has begun shipping the product, a generic equivalent of Nitrolingual Pumpspray from Arbor Pharmaceuticals Inc.
Perrigo reported that it was awarded 180-days of generic drug exclusivity because it was the first company to submit an abbreviated new drug application (ANDA) containing a paragraph IV certification.
Nitrolingual spray is indicated for the relieving a sudden attack of angina (chest pain) as a result of coronary artery disease. The medication has has estimated annual sales of $65 million, according to Perrigo.
""This approval once again exemplifies how our research and development capabilities in extended topicals translate into first to market new product approvals," stated Joseph Papa, chairman, president and chief executive officer of Perrigo.
