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SGLT-2 Inhibitor Gets Turned Down by the FDA

Mar 6, 2014
 

Quality issues in the manufacturing plant prevents FDA from final approval. The investigational type 2 diabetes drug empagliflozin won’t win the FDA’s approval until "previously observed deficiencies" at a manufacturing plant are fixed. Eli Lilly and its partner, Boehringer Ingelheim, said the FDA had issued a complete response letter in regard to their application to market empagliflozin, a sodium glucose co-transporter-2 (SGLT-2) inhibitor. (See Item #8.)