The FDA database lists a supplement, dated 21 September, to an existing abbreviated new drug application for acetazolamide from a generic manufacturer. The listing gives no detail of what the supplement changes. Supplements to generic applications commonly cover manufacturing, labelling or packaging changes.
This is an administrative action on an established generic. It does not create a new indication or change how acetazolamide should be used. Acetazolamide is widely available in India, and its CDSCO status is not affected by an FDA supplement.
- No change to how acetazolamide is prescribed follows from this listing.
- Supplements to generic applications usually concern manufacturing or labelling.
- Continue to check renal function and potassium when using acetazolamide.
- Ask about sulfonamide allergy before prescribing.
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