NovaDel Pharma Inc has announced that it has entered into a licensing agreement with Par Pharmaceutical to market its nitroglycerin lingual spray.
In June 2004, NovaDel filed a New Drug Application with the US FDA seeking marketing approval for its aerosol lingual spray version of nitroglycerin under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Under PDUFA guidelines, the company said a 10-month review period is customary.
If approved as submitted, the product would be indicated 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. This will enable patients to conveniently self-administer the product.”Par Pharmaceutical is a very successful marketer of pharmaceutical products and we are delighted to have them on board as a partner for our first product submitted for approval,” said Gary A. Shangold, MD, NovaDel’s President & CEO.
Under the terms of the agreement, Par has exclusive rights to market, sell and distribute 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 double-digit royalties on sales of the product.
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. Par currently manufactures, markets or licenses more than 80 prescription drugs.