3 Sep 2025
💊FDA Determines NUTRACORT Gel Not Withdrawn for Safety Reasons
Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if all other legal and regulatory requirements are met.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's notice allows for the approval of abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, indicating potential market opportunities for generic manufacturers. This may lead to increased competition and reduced prices, impacting business owners in the pharmaceutical sector.