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news.Generex Biotechnology has reported that Generex Oral-lyn, its proprietary oral insulin spray product, has been approved for importation and commercial marketing and sale in India for the treatment of diabetes by the Central Drugs Standard Control Organization.
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The company says Generex Oral-lyn is the first non-injectable buccalinsulin approved in India. In connection with the approval, Generex has entered into a product licensing and distribution agreement with Shreya Life Sciences, an India-based pharmaceutical company. Generex and Shreya are making preparations for the commercial launch of Generex Oral-lyn in India in early 2008.
Generex Oral-lyn is delivered via the company’s proprietary RapidMist device into the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not reach the lungs.
Anna Gluskin, president and CEO of Generex, said: “This approval in a market with one of the largest numbers of patients with diabetes comes after the Indian health regulatory agency conducted a rigorous review of clinical data demonstrating the safety and efficacy of Generex Oral-lyn. This represents the first major jurisdiction to provide approval, and offers the prospect of a new treatment paradigm for diabetes and pre-diabetic conditions.”