www.fdanews.com/articles/183745-fda-rejects-intarcias-drug-pump-for-treatment-of-type-2-diabetes
FDA Rejects Intarcia's Drug Pump for Treatment of Type 2 Diabetes
September 29, 2017
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.