The FDA granted priority review status to Eliquis (apixaban), the novel oral anticoagulant being developed by Pfizer and Bristol-Myers Squibb, the firms said. The PDUFA goal date for a decision by the FDA is March 28, 2012.
The FDA issued a draft Blueprint for educating doctors on opioid drugs including long-acting and extended-release brand name and generic products. The blueprint contains core messages intended for use by continuing education providers to develop educational materials to train prescribers under the required risk evaluation and mitigation strategy (REMS) for these products. The FDA is seeking stakeholder input on the document until December 7.