Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline has been issued an approvable letter from the FDA for the drug Arixtra for a new use in the treatment of patients with acute coronary syndromes.
Subscribe to our email newsletter
Arixtra, an injectable drug, is now indicated for patients with unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI). UA/NSTEMI and STEMI are types of acute coronary syndromes.
Arixtra is currently used in patients undergoing certain types of surgery who are at risk for blood clots.
The FDA priority review was completed in six months. GSK said it will continue to work with the FDA to provide the additional information requested to complete the assessment of Arixtra for these indications.