Basic Information (Chemical, Pharmacological, Marketing Data)

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Eptifibatide (Integrilin®, Millennium Pharmaceuticals, also co-promoted by Schering-Plough/Essex), is an anti-coagulant that selectively blocks the platelet glycoprotein IIb/IIIa receptor. It reversibly binds to platelets and has a short half-life. Eptifibatide is the third inhibitor of GPIIb/IIIa that has found broad acceptance after the specific antibody Abciximab and the non-peptid Tirofiban entered the global market. The Eptifibatide molecule constitutes a cyclic heptapeptide and belongs to the class of the so called arginin-glycin-aspartat-mimetics.

The drug is sold in two strengthes : vials containing 2mg/ml (20mg totally) and 0.75mg/ml (75mg totally).

More on [ Eptifibatide ]

CFDA: FDA Latest Computer Systems Warning Letters

WL Issued to Amrex Zetron Inc
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Amrex Zetron Inc on 14 Apr 2009 by Los Angeles District Office
WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Cote, Charles J., MD
FDA Mon, 02 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Cote, Charles J., MD on 02 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Genzyme Corporation
FDA Fri, 27 Feb 2009 00:00:00 -0400
FDA Warning Letter Issued to Genzyme Corporation on 27 Feb 2009 by New England District Office
WL Issued to Hammill Manufacturing Company
FDA Tue, 06 Jan 2009 00:00:00 -0400
FDA Warning Letter Issued to Hammill Manufacturing Company on 06 Jan 2009 by Cincinnati District Office

CFDA: FDA Latest Drug GCP Warning Letters

WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Bukowski, Ronald M, MD
FDA Mon, 30 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Youabian, Inc
FDA Tue, 17 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
WL Issued to Provena St. Joseph's Medical Center IRB
FDA Thu, 12 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Provena St. Joseph's Medical Center IRB on 12 Mar 2009 by Center for Biologics Evaluation and Research
WL Issued to Paulson, Daniel M., MD
FDA Wed, 11 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research

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