DOPTELET

批准信原文要点

This Prior Approval sNDA provides for expansion of the indication to include pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

批准信原文要点

This Prior Approval sNDA provides for an update to Section 5.1 of the Prescribing Information (PI) regarding risks of thromobotic events, specifically, to add antiphospholipid syndrome as an example of an acquired risk factor. Additionally, revisions were made to the Patient Package Insert (PPI) for consistency with the PI for S-009.

批准信原文要点

This “Changes Being Effected” sNDA provides for corrections to minor numerical errors in the Doptelet prescribing information.

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of a new subsection, Section 6.2, Postmarketing Experience, to include information on hypersensitivity reactions.

批准信原文要点

This Prior Approval supplemental new drug application provides a new indication for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

批准信原文要点

This new drug application provides for the use of Doptelet® (avatrombopag) tablets for treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.