AFT Pharmaceuticals' (ASX:AFP, NZE:AFT) Scomara topical cream intended for the treatment of facial angiofibromas in tuberous sclerosis received a tentative approval from the US Food and Drug Administration (FDA), according to a Tuesday filing with the Australian bourse.
The quality, efficacy, and safety data have been evaluated, leading to tentative approval of the product labeling and claims, the filing said.
However, launch and commercialization are subject to existing "orphan exclusivity" for another product that was granted in 2022 and expires on March 22, 2029, per the filing.
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