FDA's Approval Of Generic Bayer Bovine Drug Suspended

Law360, Washington (April 12, 2013, 7:42 PM EDT) -- A Washington federal judge on Friday suspended the U.S. Food and Drug Administration's approval of Norbrook Laboratories Ltd.'s generic version of cattle medication Baytril 100, blasting the agency for virtually ignoring Bayer AG's long-running objections that the antibiotic would be used off-label in violation of the company's patent.

U.S. District Judge Rosemary M. Collyer blasted the FDA for failing to provide any evidence to the court that it considered Bayer's allegations that Norbrook's Enroflox 100 would unavoidably infringe on its Baytril patent before approving the generic...
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Case Title

BAYER HEALTHCARE, LLC v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al


Case Number

1:13-cv-00487

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Rosemary M. Collyer

Date Filed

April 10, 2013

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