FDA approves supplemental indication for eptifibatide June 8 for patients with acute coronary syndrome, including those undergoing percutaneous coronary intervention. Approval is based on data from Cor's ESPRIT trial (1"The Pink Sheet" Jan. 15, p. 7)
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Cor Therapeutics expects to file study data with FDA during the first quarter for a change in the Integrilin (eptifibatide) dosing regimen for patients undergoing coronary stent procedures.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials