From rxpgnews.com
FDA Approves Nitroglycerin Lingual Aerosol for Acute Relief of Angina Pectoris
By NovaDel Pharma Inc.
Jun 3, 2005, 10:48
NovaDel Pharma Inc. (AMEX:NVD) received an approvable letter from the U.S. Food and Drug Administration regarding its New Drug Application (NDA) for NitroMist(TM) (nitroglycerin lingual aerosol), indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
The company believes that the Food and Drug Administration will give final approval once the company completes its previously agreed-to manufacturing process validation commitments. The FDA is not requiring any additional clinical studies for approval.
"We are extremely pleased with this approvable letter which validates our lingual spray technology and our ability to successfully bring a product through the development and regulatory processes. Furthermore, it confirms the appropriateness of the 505(b)(2) NDA regulatory path for our lingual spray products which can reduce the time to approval," said Gary Shangold M.D., President and CEO of NovaDel. "We are already moving towards completion of the process-validation work required for approval and believe a complete response can be submitted to FDA in an expeditious manner."
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