Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems
This article was originally published in Pharmaceutical Approvals Monthly
BI/Lilly’s SGLT-2 inhibitor is to be manufactured in a facility that was subject to a May 2013 warning letter from FDA.
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Some analysts expect it could take six months to resolve problems at partner Boehringer Ingelheim’s German manufacturing site, where the SGLT-2 inhibitor is made. Lilly says the European filing is not affected.
FDA investigators are continuing to find contamination problems and inadequate testing, according to 20 warning letters issued in the first half of 2013, as well as a troubling trend of repeat observations at Baxter, Hospira and Apotex. Observers say to expect more sterility concerns in future warning letters, particularly involving mold, as FDA ramps up GMP enforcement at compounding pharmacies.
Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved medical products will become available under ruling against HHS.