Avalglucosidase alfa-ngpt
Nexviazyme (avalglucosidase alfa-ngpt) is an enzyme replacement therapy used to treat Pompe disease, a rare genetic disorder causing muscle weakness. It's administered intravenously as a powder for solution, with each vial containing 100 mg of the active ingredient. Manufactured by Genzyme Corporation, it's approved for prescription use. 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 | Nexviazyme (avalglucosidase alfa-ngpt) is an enzyme replacement therapy used to treat Pompe disease, a rare genetic disorder causing muscle weakness. It's administered intravenously as a powder for solution, with each vial containing 100 mg of the active ingredient. Manufactured by Genzyme Corporation, it's approved for prescription use. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Avalglucosidase alfa-ngpt",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Avalglucosidase alfa-ngpt — ANDA 761194 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761194"
}
]
|
| identifier | ANDA761194 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"drug-manufacturers",
"fda",
"health-care",
"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 | Avalglucosidase alfa-ngpt |
