re:synthetic heparin ANDA accepted by FDA
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Alchemia - Fondaparinux ANDA accepted by FDA for Review Mon, 11 May 2009 10:13:00 +1000
ASX / Media Release 11 May 2009 Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration Brisbane, Australia, 11 May 2009: Australian drug developer, Alchemia Limited (ASX:ACL), today announced that its global manufacturing and U.S. marketing partner Dr Reddy’s Laboratories (NYSE:RDY) has received notice of acceptance of its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) for Fondaparinux Sodium. Dr Reddy’s filed the ANDA in March 2009 and this notice of acceptance indicates that the ANDA will now enter a period of formal review.
Being the first generic version of fondaparinux, the application has been marked for priority review under FDA’s Generic Initiative for Value and Efficiency (the GIVE initiative). First generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. The manufacturing process for fondaparinux used by Dr Reddy’s utilizes a novel, synthetic pathway developed by Alchemia.
About Abbreviated New Drug Applications (ANDA) According to the FDA’s Center for Drug Evaluation and Research (CDER), an ANDA contains data that provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product as an alternative to the branded drug. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is equivalent to the branded drug. About Alchemia Limited – www.alchemia.com.au Alchemia is a drug discovery and development company founded on its chemistry expertise.
The Company’s lead program is fondaparinux (synthetic heparin, a generic version of GlaxoSmithKline’s Arixtra®) which is expected to generate near term revenues for the company and is partnered with Dr Reddy’s Laboratories Inc. for the U.S. market.
Alchemia’s pipeline of assets is built on two platform technologies: HyACT® (targeted cancer delivery) and VASTTM (drug discovery). HA-irinotecan, for the treatment of colorectal cancer, recently achieved positive Phase II clinical trial results. Arixtra® is a registered trademark of GlaxoSmithKline.
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