TROGARZO

批准信原文要点

This Prior Approval sBLA provides for an update to the Trogarzo labeling to add intravenous push as an option for the administration of 2,000 mg loading dose over 90 seconds in heavily treatment-experienced adult patients with multidrug resistant HIV-1 infection, failing their current antiretroviral regimen.

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 Prior Approval supplemental biologics application provides for ... new subsection, Embryo-Fetal Toxicity ... potential risk of reversible immunosuppression in infants with in utero exposure to Trogarzo; update USE IN SPECIFIC POPULATIONS, Pregnancy ...; update Patient Counseling Information with embryo-fetal toxicity information.

批准信原文要点

We also refer to our letter dated February 12, 2020, notifying you, under Section 505(o)(4) of the FDCA, of new safety information ... risk of anaphylactic reactions.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for the following changes to the US Prescribing Information: • Section 2.2 Preparation: addition of the missing word “of” in the caption for Table 1 • Section 14 Clinical Studies: removal of the specifie…