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# FDA Withdraws Miles Laboratories ANDA
- URL: https://www.fdaweb.com/fda-withdraws-miles-laboratories-anda/
- Published: 2023-02-17T12:00:00.000Z
- Updated: 2026-09-14T18:16:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153809

*Federal Register* notice: FDA is withdrawing a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the company has repeatedly failed to file required annual reports and the agency has scientific data and experience to show it is unsafe for use. The drug is indicated to provide increased caloric intake. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-17/pdf/2023-03367.pdf?ref=fdaweb.com).