avatrombopag maleate
Drug Details
- Generic Name
- avatrombopag maleate
- Brand Names
- DOPTELET
- Application Number
- NDA210238
- Sponsor
- AkaRx, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- AVATROMBOPAG MALEATE
Indications and Usage
1 INDICATIONS AND USAGE DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. ( 1.2 ) Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment ( 1.3 ) 1.1 Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. 1.2 Treatment of Thrombocytopenia in Adult Patients with Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. 1.3 Treatment of Thrombocytopenia in Pediatric Patients 1 Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.