Federal Register #FDA-2025-P-0394

FDA Notice: SULFADIAZINE 500 mg Tablet Not Withdrawn for Safety—Generic Approval Enabled

This FDA notice is relevant to pharmaceutical manufacturers considering generic drug production. - Government buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and vendors mentioned: - Eli Lilly and Co. (original manufacturer of SULFADIAZINE tablet, 500 mg) - Products/services referenced: - SULFADIAZINE (sulfadiazine) tablet, 500 mg - Unique or notable requirements: - FDA confirms the original drug was not withdrawn for safety or effectiveness reasons - Enables approval of generic versions via abbreviated new drug applications (ANDAs) - No procurement or award is announced; notice is informational for potential generic manufacturers

Description

The Food and Drug Administration (FDA) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for this drug if all other legal and regulatory requirements are met. The drug was discontinued but not for safety or effectiveness reasons, enabling generic versions to be approved. The FDA reviewed records and literature and found no evidence of withdrawal due to safety or effectiveness concerns.

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