mirdametinib
Drug Details
- Generic Name
- mirdametinib
- Brand Names
- Gomekli
- Application Number
- NDA219389
- Sponsor
- SpringWorks Therapeutics, Inc.
- NDC Codes
- 3
- Dosage Forms
- CAPSULE, TABLET, FOR SUSPENSION
- Routes
- ORAL
- Active Ingredients
- MIRDAMETINIB
Indications and Usage
1 INDICATIONS AND USAGE GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection [see Clinical Studies (14) ]. GOMEKLI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. ( 1 )