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BAYER HEALTHCARE, LLC v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:13-cv-00487
Court:
Nature of Suit:
Judge:
Firms
Government Agencies
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April 26, 2013
FDA Flubbed Approval Of Generic Cattle Med, Judge Says
A Washington federal judge unsealed a sharply worded opinion Friday explaining her decision to suspend approval of a generic version of Bayer AG's patented cattle medication Baytril 100, saying the U.S. Food and Drug Administration had presented an "exceptionally weak" argument for allowing a rival product.
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April 12, 2013
FDA's Approval Of Generic Bayer Bovine Drug Suspended
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.
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April 11, 2013
Bayer Sues FDA Over Approval Of Generic Cattle Antibiotic
Bayer AG on Wednesday sued the U.S. Food and Drug Administration in Washington federal court over the agency's recent approval of a generic version of cattle medication Baytril 100, saying the cloned product will inevitably be used in an off-label manner that violates a company patent.