The U.S. Food and Drug Administration previously granted final approval of this Abbreviated New Drug Application.

According to industry sales data, the 10mg strength of Afinitor generated annual sales of $392 million during the twelve months ending July 2021. Breckenridge previously launched Everolimus tablets in 2.5mg, 5mg and 7.5mg strengths during the first quarter of 2021 in the US market.