NitroMist
Generic name: nitroglycerin
Treatment for: Angina
FDA Accepts Submission for NitroMist as Complete Response
FLEMINGTON, N.J., May 26, 2006 - NovaDel Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission regarding its New Drug Application (NDA) for NitroMist as a complete response. As previously disclosed, on June 1, 2005, the FDA requested that NovaDel provide certain additional manufacturing process validation data. NovaDel submitted those materials to the FDA on May 3, 2006. Therefore, the FDA has indicated a target of early November 2006 for action on the submission. NitroMist is NovaDel's nitroglycerin lingual aerosol drug candidate for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Posted: May 2006
Related articles
- NitroMist NovaDel Pharma - Treatment for Angina Pectoris - November 2, 2006
- NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol - June 2, 2005
- NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for Review by FDA - September 29, 2004
- NovaDel Pharma files for US FDA approval of Nitroglycerin Lingual Spray, its first product - June 21, 2004
NitroMist (nitroglycerin) FDA Approval History
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