NitroMistTreatment for Angina Pectoris
Update: NitroMist Now FDA Approved - November 2, 2006
NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol
No clinical issues identified
Completion of process validation needed to gain approval
Plans in place for Par to launch upon approval
FLEMINGTON, N.J., June 2, 2005 -- 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 (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."
NovaDel has partnered with Par Pharmaceutical Companies, Inc. (NYSE:PRX) who has exclusive rights to market, sell and distribute NitroMist in the US and Canada. NovaDel receives milestone payments and royalties on sales of the product. Manufacturing of the product will occur at the Manati, Puerto Rico facility of Inyx, Inc. (OTCBB:IYXI).
NitroMist is a pending trademark of Par Pharmaceutical Companies, Inc.
About NovaDel Pharma, Inc.
NovaDel Pharma, Inc. is a specialty pharmaceutical company engaged in the development of novel drug delivery systems for prescription and over-the-counter drugs. The company's proprietary lingual spray technology delivery system offers the patient the potential for (i) fast onset of action; (ii) improved drug safety by reducing the required drug dosage and reducing side effects; (iii) improved patient convenience and compliance; and (iv) enhanced dosage reliability. The company plans to develop such products independently and through collaborative arrangements with major pharmaceutical and biotech companies.
Posted: June 2005
- NitroMist NovaDel Pharma - Treatment for Angina Pectoris - November 2, 2006
- FDA Accepts Submission for NitroMist as Complete Response - May 26, 2006
- 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