Sebetralstat
EKTERLY (sebetralstat) is a prescription oral tablet from KalVista Pharmaceuticals, approved under NDA219301. It inhibits plasma kallikrein to help manage hereditary angioedema attacks. Each tablet contains 300 mg of sebetralstat, available in blister packs starting July 2025. 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 | EKTERLY (sebetralstat) is a prescription oral tablet from KalVista Pharmaceuticals, approved under NDA219301. It inhibits plasma kallikrein to help manage hereditary angioedema attacks. Each tablet contains 300 mg of sebetralstat, available in blister packs starting July 2025. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[ { "@type": "dcat:Distribution", "title": "Sebetralstat", "mediaType": "text/html", "description": " Access the FDA dataset for Sebetralstat — ANDA 219301 submitted by Mylan Institutional LLC ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219301" } ] |
| identifier | ANDA219301 |
| issued | 2016-09-16 |
| keyword |
[ "drug-safety", "fda", "medications", "prescription-drugs", "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 | Sebetralstat |
