Lilly’s Diabetes Pill Rejected by FDA Over Manufacturing
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A diabetes pill developed by Eli Lilly & Co. and Boehringer Ingelheim GmbH was rejected by U.S. regulators because of previously disclosed manufacturing deficiencies at a German plant that hadn’t been resolved.
The Food and Drug Administration inspected Boehringer’s Ingelheim am Rhein facility in 2012 and warned the Ingelheim-based company of the faults in May 2013. No new clinical studies will be needed to approved the drug, called empagliflozin, the companies said today in a statement.