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# Cedax Not Withdrawn Over Safety or Effectiveness
- URL: https://www.fdaweb.com/cedax-not-withdrawn-over-safety-or-effectiveness/
- Published: 2017-04-05T12:00:00.000Z
- Updated: 2026-09-14T22:16:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138387

*Federal Register* Notice: FDA has determined that Pernix Therapeutics’ antibiotic Cedax (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn for reasons involving safety or effectiveness. This determination will allow the agency to approve ANDAs for ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-04-05/pdf/2017-06701.pdf?ref=fdaweb.com).