Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration
11 Maio 2009 - 9:00AM
Business Wire
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.VASTTM and
HyACT� are trademarks of Alchemia and Alchemia Oncology.
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