ALIQOPA

批准信原文要点

This Prior Approval sNDA provides for revisions to the Dosage and Administration subsection 2.4, to include dosage modification for patients that develop cytomegalovirus (CMV) infection or viremia, the Warnings and Precautions subsection 5.1, to include information regarding CMV infection, and the Clinical Pharmacology subsection 12.3, to include clinical data from Study 19951.

批准信原文要点

This Prior Approval sNDA provides for updates to the US Prescribing Information (USPI): Section 12.2 Pharmacodynamics based on additional QTc data and edits to the USPI section 12.3 Pharmacokinetics related to PK data from patients with severe hepatic impairment.

批准信原文要点

This prior approval sNDA provides revisions to Section 2 Dosage and Administration Subsection 2.2, and Section 8 Use in Specific Populations Subsection 8.6, to reflect a dose reduction of Aliqopa to 30 mg in patients with severe hepatic impairment, and revisions to Section 12 Clinical Pharmacology Subsection 12.3, to include data from Study 18041 to support the dose reduction in patients with severe hepatic impairment.

批准信原文要点

This new drug application provides for the use of ALIQOPA™ (copanlisib) for injection, 60mg, for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for updates to the US Prescribing Information to the “Recent Major Changes” heading in the Highlights section and identify the recent major change with a vertical line in the relevant subsection of the Fu…

批准信原文要点

This Prior Approval supplemental new drug application provides for the following updates in the United States Prescribing Information (USPI): revised the order of subsections in Dosage and Administration, added dosing recommendations and pharmacokinetic (PK) data for patients with hepatic impairment, reformatted drug interaction information, and added information regarding QTc prolongation based on findings from study 16270.

批准信原文要点

This Prior Approval supplemental new drug application provides for editorial and labeling guidance compliance updates to the United States Prescribing Information (USPI).