CABLIVI

批准信原文要点

This Prior Approval sBLA proposes updates to the Prescribing Information (PI) and the Instructions for Use to expand the current indication to include adolescents aged 12 years and older and to update the PI Section 6.1 Clinical Trials and Section 14 Clinical Studies with safety and efficacy information based on study OBS17325.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for editorial revisions to the Instructions for Use.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for revisions to the Prescribing Information in the Postmarketing Experience section to include injection site reactions including injection site pain, injection site bruising and injection site erythema.

批准信原文要点

We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for modifications to Section 6… to include “injection site erythema” under Section 6.3 – Postmarketing Experience.