Bayer AG (BAYN) won an agreement from the U.S. Food and Drug Administration to block sales of a generic form of the livestock antibiotic Baytril 100 made by Norbrook Laboratories Ltd.
The FDA on April 19 agreed to withhold its approval of Norbrook’s Enroflox 100 product to treat bovine respiratory disease. The decision comes two days after a federal judge in Washington ruled that the agency offered no evidence it considered Leverkusen, Germany-based Bayer’s concerns that the generic would be used for a so-called off-label dosage.
“FDA itself acknowledges that its action has not been regular; it failed to respond to the citizen petition for years and failed to provide a reasoned basis for rejecting it before approving Enroflox,” U.S. District Judge Rosemary Collyer said in an opinion made public today.
The FDA approved Norbrook’s application for Enroflox on March 29. 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 sued the FDA on April 10, alleging it told the agency in 2006 that the generic version of its product will be used in a single dose.
Christopher Kelly, an FDA spokesman, said the agency didn’t have an immediate comment on the agreement. A woman who answered the phone at Norbrook’s U.S. office in Lenexa, Kansas, and wouldn’t identify herself said the company would have no comment on the matter.
The case is Bayer Healthcare LLC v. U.S. Food and Drug Administration, 13-cv-00487, U.S. District Court, District of Columbia (Washington).
To contact the reporter on this story: Tom Schoenberg in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Michael Hytha at email@example.com