GlaxoSmithKline (Jobs) Receives Approvable Letter For New Indications For ARIXTRA(R) (Fondaparinux Sodium) Injection
Published: Feb 02, 2007
-- Unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) -- ST-segment elevation myocardial infarction (STEMI). UA/NSTEMI and STEMI are types of acute coronary syndromes (ACS).
The FDA priority review was completed in six months. GSK will continue to work with the FDA to provide the additional information requested to complete the assessment of ARIXTRA for these indications. The company looks forward to making ARIXTRA available as an additional treatment option for the care of a broad range of patients with acute coronary syndromes. Results of the clinical studies (OASIS 5 and OASIS 6) supporting these two New Drug Applications have been presented and published in New England Journal of Medicine and Journal of the American Medical Association, respectively.
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CONTACT: Jennifer Armstrong GlaxoSmithKline 919-483-2839