cGMPs / QRM Process

FDA Rejects Lilly, Boehringer Diabetes Drug Due to Previous cGMP Violations

Mar 06, 2014

Eli Lilly and Co and partner Boehringer Ingelheim announced on Wednesday that the FDA has declined to approve the experimental diabetes drug empagliflozin, citing previously observed quality issues at a Boehringer facility where the GLT2 inhibitor would be manufactured.

The FDA issued a warning letter in May 2013 citing problems it found at the Boehringer plant in Ingelheim am Rhein, Germany, during an inspection six month earlier and noting that  "insufficient corrective actions" had been taken.  Among other issues, the FDA said it had detected foreign particles in batches of active pharmaceutical ingredients.

The drugmakers, in a joint press release, noted that the FDA has not asked Boehringer to complete any new clinical trials to support the approval of the application. Both drugmakers are committed to working with the FDA and submitting a response to the complete response letter as soon as possible.