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# FDA Sends Intarcia Complete Response Letter
- URL: https://www.fdaweb.com/fda-sends-intarcia-complete-response-letter/
- Published: 2020-03-11T12:00:00.000Z
- Updated: 2026-09-14T16:06:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146302

For a second time, FDA has rejected an Intarcia Therapeutics implant intended to treat Type 2 diabetes by providing a steady supply of reformulated exenatide to diabetes patients. The agency sent the company a complete response letter, according to the *Endpoints* online [newsletter](https://endpts.com/intarcias-speed-bump-at-the-fda-turns-into-a-roadblock-as-regulators-once-again-turn-thumbs-down-on-diabetes-drug-device/?ref=fdaweb.com). The company said it was “extremely disappointed with the receipt of a complete response letter from FDA. We remain steadfast in our belief that ITCA 650 holds important potential as a new treatment option for people managing Type 2 diabetes. We anticipate meeting with the division for our end of review meeting to make sure we understand the situation and the path forward.”