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AlphaRx Inc. (ALRX) Provides Update On Its Antibiotic Development Program
7/18/2005
MARKHAM, ON--(MARKET WIRE)--Jul 18, 2005 -- AlphaRx Inc. (OTC BB:ALRX.OB - News), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to provide a strategic overview of the Company's antibiotic development program. The Company, using its patent pending solid lipid nanoparticle delivery platform, is developing 3 antibiotic products: Rifamsolin™, Zysolin™ and Ocusolin™, targeting the treatment of tuberculosis, hospital acquired pneumonia (HAP) and ocular infection respectively. The Company's regulatory strategy for these products is to focus on obtaining market entry as quickly as possible. One part of the strategy is to seek approval through an FDA 505(b)(2) New Drug Application (NDA), by comparing the Company's products to currently marketed products with similar clinical indications. Under the 505(b)(2) regulation, an NDA may rely on data of an FDA approved drug submitted by another sponsor, from whom right of reference has not been obtained. In parallel with the 505B(b)(2) program, the Company is seeking marketing approval for these products in countries where these indications may receive fast track designation.
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