Larotrectinib
Vitrakvi (larotrectinib) is an oral solution that inhibits tropomyosin receptor kinases, prescribed for certain cancers with NTRK gene fusions. It's a 20 mg/mL concentrate manufactured by Bayer HealthCare Pharmaceuticals Inc. and approved under NDA211710 in December 2022. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Vitrakvi (larotrectinib) is an oral solution that inhibits tropomyosin receptor kinases, prescribed for certain cancers with NTRK gene fusions. It's a 20 mg/mL concentrate manufactured by Bayer HealthCare Pharmaceuticals Inc. and approved under NDA211710 in December 2022. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Larotrectinib",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Larotrectinib — ANDA 211710 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211710"
}
]
|
| identifier | ANDA211710 |
| issued | 2016-09-16 |
| keyword |
[
"drug-safety",
"health-care",
"medications",
"pharmaceuticals",
"public-health"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Larotrectinib |
