FDA approves Perrigo angina pectoris drug

Perrigo awarded 180 days' market exclusivity for generic nitroglycerin lingual spray

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

The FDA approved Perrigo's nitroglycerin lingual spray in the 400-mcg-per-spray strength. The drug is used to relieve attacks of or prevent angina pectoris due to coronary artery disease.

The drug is a generic version of Arbor Pharmaceuticals' Nitrolingual Pumpspray, which has sales of about $65 million, according to Perrigo. As the first company to win approval for the generic version, Perrigo has 180 days in which to compete exclusively against Arbor.

 

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