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Home » APOTEX APPEAL OVER GENERIC PLAVIX DISMISSED BY CANADIAN COURT
APOTEX APPEAL OVER GENERIC PLAVIX DISMISSED BY CANADIAN COURT
A federal appeals court in Canada rejected an appeal filed by Apotex to overturn a judgment that blocks the company from obtaining regulatory clearance needed to market clopidogrel bisulfate, a generic version of Bristol-Myers-Squibb's (BMS) heart drug, Plavix, BMS and sanofi-aventis said Dec. 28.
Apotex had filed an appeal with the Canadian Federal Court of Appeals to reverse a Federal Court of Canada ruling that prohibits the Health Ministry from issuing a compliance notice in connection with the company's plan to sell generic clopidogrel bisulfate in 75-mg doses.
Without such notice, Apotex is not allowed to market its generic drug in Canada, according to BMS.
KEYWORDS FDAnews Drug Daily Bulletin
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