Empagliflozin Approval May Come This Year After Boehringer Resolves GMP Problems
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
BI/Lilly’s SGLT-2 inhibitor is to be manufactured in a facility that was subject to a May 2013 warning letter from FDA.
You may also be interested in...
Manufacturing Woes Result In “Complete Response” For Lilly’s Empagliflozin
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.
Contamination and Raw Material Testing Issues Raised in FDA Warning Letters
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.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.