# VYONDYS 53
> **NDA211970** · New Drug Application · Sponsor: SAREPTA THERAPS INC · Approved 2019-12-12
## Drug
- **FDA Application Number:** NDA211970
- **Application type:** New Drug Application
- **Brand name:** VYONDYS 53
- **Generic name:** GOLODIRSEN
- **Active ingredients:** GOLODIRSEN
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** SAREPTA THERAPS INC
- **Manufacturer:** Sarepta Therapeutics, Inc.
- **First approval:** 2019-12-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211970)
---
*AI Analytics · CC0 1.0*