When is a medicine currently under review by the TGA not under evaluation?

MAESTrO Database

1 February 2021 - The approval of the first new medicine for 2021 raises an interesting question.

On 11 January 2021, the TGA approved Aklief (trifarotene) for the topical treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present. Aklief was entered onto the ARTG on 18 January 2021.

On 15 January 2021, the TGA published a list of applications for new medicines or new uses for existing medicines that were under evaluation by the TGA as at 15 January 2021. Alkief was not in the list.

This begs the question as to a medicine that has been approved by the TGA Delegate but has not been entered onto the ARTG is still under evaluation. The answer appears to be no.

Michael Wonder

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Michael Wonder