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Medical Devices / Submissions and Approvals

FDA Rejects Intarcia's Drug Pump for Treatment of Type 2 Diabetes

Oct. 2, 2017
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The FDA rejected Intarica Therapeutics’s manufacturing plan for a matchstick-sized drug pump for the treatment of Type 2 diabetes.

The ITCA 650 device is inserted into the abdomen and gradually pumps tiny amounts of a drug into the bloodstream over the course of six months or a year.

The device outperformed Merck’s blockbuster drug, Januvia, in a head-to-head trial last year.

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