Casimersen
AMONDYS 45 (casimersen) is an intravenous solution used to treat Duchenne muscular dystrophy in patients with a specific genetic mutation. It works as an antisense oligonucleotide to increase protein synthesis. Manufactured by Sarepta Therapeutics, Inc., it's available as a 50 mg/mL injection in single-use vials. This information was generated using AI and is provided for informational and research purposes only.
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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 | AMONDYS 45 (casimersen) is an intravenous solution used to treat Duchenne muscular dystrophy in patients with a specific genetic mutation. It works as an antisense oligonucleotide to increase protein synthesis. Manufactured by Sarepta Therapeutics, Inc., it's available as a 50 mg/mL injection in single-use vials. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Casimersen",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Casimersen — ANDA 213026 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213026"
}
]
|
| identifier | ANDA213026 |
| issued | 2016-09-16 |
| keyword |
[
"fda",
"health-care",
"medications",
"pharmaceuticals",
"prescription-drugs"
]
|
| 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 | Casimersen |
