Sublingual Nitroglycerin Powder NDA Accepted for Review

Espero Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro (nitroglycerin) for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

RELATED: Angina Patient Information Sheet

Espero has an exclusive Licensing and Distribution Agreement with Pohl-Boskamp, the German developer of the product and also the owner of the Nitrolingual Pumpspray NDA approved in 1997.

The FDA has set an action date of June 10, 2016 to complete its review, as per the Prescription Drug User Fee Act (PDUFA).

GoNitro is a powder formulation of nitroglycerin for sublingual use.

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