mirdametinib
mirdametinib is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Gomekli. Available dosage forms: tablet, for suspension, capsule.
Drug Details
- Generic Name
- mirdametinib
- Brand Names
- Gomekli
- Application Number
- NDA219379
- Sponsor
- SpringWorks Therapeutics, Inc.
- NDC Codes
- 6
- Dosage Forms
- TABLET, FOR SUSPENSION, CAPSULE
- 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 )