FDA approves supplement for Novartis's Kisqali Femara Co-Pack
A priority efficacy supplement for the combination tablet package was approved, with the label update dated July 10, 2026.
The FDA approved a new supplement for the "KISQALI FEMARA CO-PACK (COPACKAGED)" application, a copackaged oral tablet product containing letrozole at 2.5MG and ribociclib succinate equivalent to 200MG base, sponsored by Novartis.1
The submission was designated as supplement number 33 under application NDA209935, and it was classified as an Efficacy submission with a review priority of Priority, according to the filing record. submission_status: AP1 indicates the supplement was approved.
The record lists a status date of 2026-07-01 for the submission. Supporting application documents include an approval letter dated July 6, 2026, and an updated product label dated July 10, 2026, both filed under application number 209935.
The documents provided do not include additional details on the specific clinical or manufacturing changes addressed by this supplement, nor do they specify the indication or patient population affected by the update. Readers seeking the substance of the labeling change should consult the linked FDA letter and label documents directly, as those specifics are not detailed in the available record.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.