# Federal Register notice 2021-18928

> The Federal Register published notice 2021-18928, attributed to FDA and its parent HHS department, on 2021-09-02. Its official title is “Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide.

- Evidence object: `story:federal-register-2021-18928:v1`
- Evidence domain: Regulatory
- Date in source: 2021-09-02
- Source checked: 2026-08-21
- Published by PeptideScanner: 2026-08-21
- Story landing page: https://peptidescanner.com/stories/federal-register-2021-18928/
- JSON record: https://peptidescanner.com/evidence/v1/objects/federal-register-2021-18928-v1.json
- Content SHA-256: `3bfb54ee178f4b4745e7b0877e8b579cfc9caec29aa3dd3cd06c8ebecb0a9aab`

## Claims and source pins

### Headline

Federal Register notice 2021-18928 ([`federal-register-2021-18928-8239c587d848`](#source-federal-register-2021-18928-8239c587d848))

### Summary

The Federal Register published notice 2021-18928, attributed to FDA and its parent HHS department, on 2021-09-02. Its official title is “Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide. ([`federal-register-2021-18928-8239c587d848`](#source-federal-register-2021-18928-8239c587d848))

### Paragraph 1

The Federal Register published notice 2021-18928, attributed to FDA and its parent HHS department, on 2021-09-02. Its official title is “Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide. ([`federal-register-2021-18928-8239c587d848`](#source-federal-register-2021-18928-8239c587d848))

### Paragraph 2

This page reports bounded metadata from a Federal Register document attributed to FDA and its parent HHS department, and links to the official GovInfo PDF. It does not interpret legal effect, approval, safety, effectiveness, compounding status, or medical use. ([`federal-register-2021-18928-8239c587d848`](#source-federal-register-2021-18928-8239c587d848))

## Sources

<a id="source-federal-register-2021-18928-8239c587d848"></a>
- **Federal Register notice 2021-18928 · published 2021-09-02 · Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing** — Federal Register via GovInfo; class A. [Open source](https://www.govinfo.gov/content/pkg/FR-2021-09-02/pdf/2021-18928.pdf) (`federal-register-2021-18928-8239c587d848`)

## Correction lineage

No correction is recorded for this version.

## Reporting boundaries and unknowns

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- Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.
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## Suggested citation

PeptideScanner. "Federal Register notice 2021-18928." Version 1, published 2026-08-21. https://peptidescanner.com/evidence/v1/objects/federal-register-2021-18928-v1.json SHA-256: 3bfb54ee178f4b4745e7b0877e8b579cfc9caec29aa3dd3cd06c8ebecb0a9aab.