NitroMist
Treatment for Angina PectorisUpdate: NitroMist Now FDA Approved - November 2, 2006
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
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