Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says
In citizen petition response involving Takeda's Velcade, agency says ANDA and 505(b)(2) applicants may add more words to the indication statement in order to carve-out protected uses from the reference product's broadly written indication.
You may also be interested in...
Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases
Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.
CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.
However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.