Apotex Says FDA Botched Plant Evaluation In Drug Approvals

Law360, New York (October 4, 2012, 1:23 PM EDT) -- Generics maker Apotex Inc. sued federal health officials in Washington federal court on Wednesday, claiming they're improperly holding up Apotex from selling two blood pressure medications by failing to approve the drugs' manufacturing facility, giving a leg up to the drugmaker's competitors.

The suit claims that the U.S. Food and Drug Administration failed to confirm that an Apotex plant in Bangalore, India, met good manufacturing standards in order to approve the company's two abbreviated new drug applications for generic irbesartan, despite clearing the plant for other...
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Case Information

Case Title

APOTEX INCORPORATED et al v. DEPARTMENT OF HEALTH & HUMAN SERVICES et al


Case Number

1:12-cv-01647

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Richard J. Leon

Date Filed

October 3, 2012

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