The FDA requested on June 1, 2005 that NovaDel provide certain additional manufacturing process validation data which the company submitted on May 3, 2006. After confirming that the additional data properly addresses its previous concerns, the FDA has now 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.
According to NovaDel, its oral spray technology delivery system offers the patient the potential for fast onset of action, improved drug safety by reducing the required drug dosage and reducing side effects, improved patient convenience and compliance, and enhanced dosage reliability.
The company further said that it plans to develop such products independently and through collaborative arrangements with major pharmaceutical and biotech companies.