Par Pharmaceutical Companies Inc has entered into a licensing agreement with developer NovaDel Pharma Inc to market an aerosol nitroglycerin lingual spray.
In June 2004, NovaDel submitted a New Drug Application, pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, to the US Food and Drug Administration seeking marketing approval for the product. Aerosol nitroglycerin lingual spray is intended for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. The product is delivered via a metered dose dispenser designed to ensure accurate dose delivery, enabling patients to conveniently self-administer the product.
Under the terms of the agreement, Par has 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, a release from Par pharma said.
NovaDel Pharma Inc, located in Flemington, NJ, is a specialty pharmaceutical company engaged in the development of novel drug delivery systems for prescription and over-the-counter drugs.
Par Pharmaceutical Companies Inc develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005.