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.
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.