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# Claforan Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/claforan-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:36:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144471

*Federal Register* notice: FDA has determined that U.S. Pharmaceutical Holdings’ Claforan (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDA approvals that reference the drug product, and it will allow the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Claforan was initially approved on 3/1981, and is indicated for treating patients with serious bacterial infections in eight different organ systems caused by susceptible strains of microorganisms. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-03/pdf/2019-14172.pdf?ref=fdaweb.com).