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Diabetes Drug Rejected by FDA Due to Manufacturing Issues

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Eli Lilly & Co., along with Boehringer Ingelheim GmbH, developed a new diabetes pill called empagliflozin to be manufactured by a German plant.  However, the FDA refuses to approve distribution of the drug in the U.S. because of previously discovered issues at Boehringer's Ingelheim am Rhein facility.  In 2012, the FDA warned the company of the issues that would need to be addressed before it would approve any drugs originating from that plant for distribution in the U.S.  This new drug is projected to sell $295 million for Eli Lilly in 2019, provided there are no major interventions to impede its distribution worldwide.  The FDA is currently continuing inspections of the German plant for production, processes, contamination issues, and quality assurance, but approval will take several more months.

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