NitroMist
Generic name: nitroglycerin
Treatment for: Angina
NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for Review by FDA
Par Pharmaceutical Has Exclusive Rights To U.S. And Canada
FLEMINGTON, N.J., September 29, 2004 -- NovaDel Pharma Inc. (AMEX:NVD) today announced that the NDA for its aerosol nitroglycerin lingual spray has been accepted for review by the Food and Drug Administration (FDA). If approved as submitted, the product will be indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
The submission was made as a 505(b)(2) application, a form of NDA that references and relies on data developed by NovaDel and historical data published in the literature. The Prescription Drug User Act (PDUFA) goal date is June 4, 2005.
On Sept. 7, NovaDel and Par Pharmaceutical Companies, Inc. (NYSE:PRX) announced an agreement granting Par exclusive rights to market, sell and distribute aerosol nitroglycerin lingual spray in the US and Canada. NovaDel is responsible for obtaining regulatory approval for the product and for supplying the product to Par. NovaDel will receive milestone payments and royalties on sales of the product.
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: September 2004
Related articles
- NitroMist NovaDel Pharma - Treatment for Angina Pectoris - November 2, 2006
- FDA Accepts Submission for NitroMist as Complete Response - May 26, 2006
- NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol - June 2, 2005
- 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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