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duration nitroglycerin emt NovaDel Pharma files for US FDA approval of Nitroglycerin Lingual Spray, its firstproduct The submission was made as a 505(b)(2) application, a form of NDA that referencesand relies both on data developed by NovaDel as well as on the wealth of historicaldata published in the literature duration nitroglycerin emt. The 505(b)(2) was filed under PDUFA guidelines,under which a 10-month review is typical, the company said. “This is an important step as it demonstrates NovaDel’s capabilityto complete the pharmaceutical and clinical development activities to supporta submission needed for marketing approval,” said Gary A duration nitroglycerin emt. Shangold, MD,NovaDel’s president and CEO duration nitroglycerin emt. This is the first of NovaDel’s six TierOne priority products to reach the stage of NDA submission. The next leading product in NovaDel’s Tier One portfolio is a lingualspray version of GlaxoSmithKline’s Imitrex (sumatriptan), the leading migraineremedy duration nitroglycerin emt. A pilot clinical pharmacokinetic study was initiated last month. At the Annual Meeting of the American Association of Pharmaceutical Scientistsheld October 2003 in Salt Lake City, the company reported results of a randomized,double-blind, placebo controlled, four-way crossover study of its nitroglycerinlingual spray in 30 patients with chronic stable angina pectoris duration nitroglycerin emt. The threenitroglycerin lingual spray doses (0.2, 0.4 and 0.8 mgs) were well toleratedand produced positive changes in hemodynamic endpoints both at rest and duringtreadmill exercise. The study showed highly statistically significant and clinically meaningfuldose-dependent increases vs duration nitroglycerin emt. placebo in the amount of treadmill exercise timeneeded to provoke the first onset of angina and to develop moderate angina. The important anti-ischemic effects of NovaDel’s nitroglycerin lingualspray were also evidenced by the prolongation of the time to 1mm ST segmentdepression and the subjects’ ability to exercise to a higher rate-pressureproduct. The company earlier reported its plans to complete pilot clinical pharmacokineticstudies this year on lingual spray versions of three other currently marketeddrugs: Glaxo’s Zofran (ondansetron), Sanofi’s Ambien (zolpidem), andXanax (alprazolam), sold by Pfizer and several generic producers duration nitroglycerin emt. In addition,the company is co-developing, with Manhattan Pharmaceuticals, Inc duration nitroglycerin emt. (OTCBB: MHTT),a lingual spray version of propofol, the leading general IV anesthetic, as afast-acting, quick-recovery sedative for invasive procedures performed in anout-patient setting. |
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