FDA's drug approvals database lists a supplement dated 25 September 2026 to an abbreviated new drug application for ketoconazole held by Padagis Israel. The listing does not say which formulation is involved or what the supplement changed; supplements to generic applications are most often manufacturing, labelling or packaging updates.
This is an administrative action on an established generic, not a new indication or a safety finding. It is a reasonable moment to recall the standing safety position on the oral drug: FDA restricted oral ketoconazole in 2013 because of liver injury, adrenal insufficiency and drug interactions, and it is not a first-line treatment for any fungal infection. Topical ketoconazole does not carry those systemic risks.
- Oral ketoconazole is not first line for any fungal infection because of liver injury and adrenal suppression.
- If oral ketoconazole is used, check liver function before and during treatment.
- Oral ketoconazole is a strong CYP3A4 inhibitor; check every co-prescribed drug for interactions.
- Topical ketoconazole remains a standard treatment for seborrhoeic dermatitis and superficial skin infections.
Why it matters
Nothing about ketoconazole's place in treatment changes with this listing.
Don't overread it
A supplement to a generic application is not a new indication or a safety signal.
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