FDA Flubbed Approval Of Generic Cattle Med, Judge Says

Law360, New York (April 26, 2013, 3:59 PM ET) -- 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.

In her April 17 opinion, U.S. District Judge Rosemary M. Collyer torched the FDA for failing to respond to a citizen petition Bayer submitted in 2006 arguing that cloned versions of antimicrobial solution Baytril approved for multiday treatments would inevitably...
To view the full article, register now.