NovaDel: FDA accepts submission for NitroMist as complete response

By E. Janene Geiss

Philadelphia, May 26 - NovaDel Pharma Inc. said Friday that the Food and Drug Administration has accepted the company's submission regarding its New Drug Application for NitroMist as a complete response.

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, according to a company news release.

The FDA has indicated a target of early November for action on the submission, officials said.

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.

Flemington, N.J.-based NovaDel is a specialty pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.