Chemex announces delay in NDA acceptance with no impact on its plans.FORT LEE, N.J.--(BUSINESS WIRE)--Nov. 17, 1994--Chemex Pharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CHMX) on behalf of its joint venture with Block Drug Co., announced today that it has been informed by the Food & Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") that preliminary review of its New Drug Application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") for Amlexanox, for the treatment of aphthous ulcers ("canker sores Canker Sores Definition Canker sores are small sores or ulcers that appear inside the mouth. They are painful, self-healing, and can recur. Description ") has been completed. The NDA has been granted a priority review status since there are no other drugs available for treatment of canker sores. However, priority assignment also means that the manufacturing plants for the product be immediately available for inspection by the FDA. Since the bulk drug manufacturer, located outside the U.S., is undergoing renovation, the facility will not be available for inspection until April 1, 1995. Accordingly, the FDA has refused to accept the NDA for further review, Chemex, on behalf of the joint venture, will refile the NDA on or about April 1, 1995 when the plant is available for inspection. Because the NDA has been granted priority review, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the latest FDA guidelines, the NDA review should be completed within six months. It is anticipated that the NDA would be accepted by the FDA shortly after refiling, with anticipated approval of the NDA in the fourth quarter of 1995, the original time frame for approval anticipated by the company. Herbert H. McDade Jr., chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , stated, "The delay in NDA acceptance for Amlexanox has no impact on our original plans. We submitted a fully documented NDA, which upon review, was delayed due to plan availability, but otherwise acceptable. The fact that we have received a priority review status maintains the integrity of our launch plans for the product." Chemex is a leader in developing new prescription drugs for the treatment of various skin diseases. CONTACT: Chemex Pharmaceuticals Inc., Fort Lee Len Stigliano, 201/944-1449 |
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