Selumetinib
Koselugo (selumetinib) is a prescription oral medication manufactured by AstraZeneca Pharmaceuticals LP. It acts as a kinase inhibitor, targeting MEK1 and MEK2 enzymes. Available in capsule forms (10mg and 25mg) and granules (equivalent to 5mg and 7.5mg base), it's used to treat certain conditions like neurofibromatosis type 1 in children. 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 | Koselugo (selumetinib) is a prescription oral medication manufactured by AstraZeneca Pharmaceuticals LP. It acts as a kinase inhibitor, targeting MEK1 and MEK2 enzymes. Available in capsule forms (10mg and 25mg) and granules (equivalent to 5mg and 7.5mg base), it's used to treat certain conditions like neurofibromatosis type 1 in children. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Selumetinib",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Selumetinib — ANDA 219943 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219943"
}
]
|
| identifier | ANDA219943 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"drug-safety",
"health-care",
"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 | Selumetinib |
