FDA spurns Lilly, Boehringer diabetes drug, cites factory problem

March 5 Wed Mar 5, 2014 9:53am EST

March 5 (Reuters) - Eli Lilly and Co and partner Boehringer Ingelheim said U.S. regulators have declined to approve their experimental diabetes drug empagliflozin, citing previously observed deficiencies at a manufacturing facility where it would be made.

The drugmakers, in a joint release on Wednesday, said the U.S. Food and Drug Administration determined that deficiencies at the Boehringer Ingelheim factory would have to be resolved before the product could be approved.