NovaDel NitroMist “approvable”
This article was originally published in Pharmaceutical Approvals Monthly
NovaDel's lingual nitroglycerin spray NitroMist is "approvable" at FDA June 2 for acute relief and prevention of angina due to coronary artery disease. The outstanding issues with the firm's 505(b)(2) NDA relate to completion of manufacturing process validation, NovaDel said. The agency is not requiring any additional clinical studies. NovaDel is touting a faster onset of action and an improved safety profile compared to nitroglycerin tablets...
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