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Bayer Sues FDA Seeking to Block Sales of Generic Baytril

Bayer AG sued the U.S. Food and Drug Administration seeking to block sales of a generic form of the livestock antibiotic Baytril 100 being sold by competitor Norbrook Laboratories Ltd.

Bayer, in a complaint filed today in Washington, said the FDA’s approval of Norbrook’s Enroflox 100 product to treat bovine respiratory disease was unlawful because the agency hadn’t responded to Bayer’s concerns that the generic would be used for an off-label doseage. The Leverkusen, Germany-based company asked a judge to halt sales of the generic while the lawsuit is being considered.

“A temporary restraining order is warranted to prevent severe and irreparable harm to Bayer and to preserve the status quo until the court can reach the merits of Bayer’s claim,” Bruce Genderson, a lawyer for Bayer at Williams & Connolly LLP, said in a request for a preliminary injunction.

The FDA approved Norbrook’s application for its Enroflox product on March 29, according to the complaint. Norbrook, based in the U.K., sought FDA approval in 2008 to market a generic version of Baytril 100 that would be labeled as a multiday dosing regimen. Bayer alleges the product will be used in a single dose.

Sandy Walsh, an FDA spokeswoman, didn’t immediately respond to an e-mail seeking comment on the lawsuit.

A telephone message seeking comment on the lawsuit left at Norbrook’s U.S. office in Lenexa, Kansas, after regular business hours wasn’t immediately returned.

The case is Bayer Healthcare LLC v. U.S. Food and Drug Administration, 13-cv-00487, U.S. District Court, District of Columbia (Washington).

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