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FDA spurns Lilly, Boehringer diabetes drug, cites factory problems
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 problems at a facility where it would be made.
The drugmakers, in a joint release on Wednesday, said the U.S. Food and Drug Administration determined that issues at the Boehringer factory in Ingelheim, Germany, need to be resolved before the product could be approved.
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