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# Otect Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/otect-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151567

*Federal Register* notice: FDA has determined that Clinigen’s Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectiveness reasons. The determination means the agency can continue to approve ANDAs that reference the product, which is indicated for treating extravasation resulting from intravenous anthracycline chemotherapy and for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-07942.pdf?ref=fdaweb.com).