On 8 October FDA recorded a supplement to an abbreviated new drug application for generic tafluprost, a prostaglandin analogue eye drop, held by Micro Labs. The listing does not state what the supplement changes. Supplements to generic applications usually concern manufacturing, labelling alignment or packaging.
Nothing in the record suggests a new indication, a safety communication or a change in how tafluprost is used. The applicant is an Indian manufacturer, but the action concerns the US market; any implication for products sold in India is unknown.
- No change to tafluprost prescribing follows from this listing.
- The record does not state what the supplement changes.
- Its relevance to tafluprost supplied in India is unknown.
- Continue to counsel on the usual prostaglandin side effects, such as hyperaemia and lash growth.
Why it matters
It confirms nothing has changed for a commonly used glaucoma drop.
Don't overread it
A supplement to a generic application is not a new indication or a safety finding.
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