Boehringer Ingelheim, Eli Lilly can resubmit NDA for diabetes drug with warning letter resolved

Boehringer Ingelheim has finally received some good news for its manufacturing facility in Ingelheim, Germany. The FDA has notified it that it has closed out a warning letter for the facility. That will allow it and partner Eli Lilly ($LLY) to move forward with their applications for diabetes drug empagliflozin. The agency had issued a complete response letter for the drug candidate in March, saying it would not approve it until the problems at the plant were fixed. A Boehringer Ingelheim spokeswoman said today that "Boehringer Ingelheim will resubmit the New Drug Application for empagliflozin, its investigational SGLT2 inhibitor, as soon as possible. The exact date for resubmission is currently being determined." Story | More

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