viltolarsen
viltolarsen is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Viltepso. Available dosage form: injection, solution.
Drug Details
- Generic Name
- viltolarsen
- Brand Names
- Viltepso
- Application Number
- NDA212154
- Sponsor
- NS Pharma, Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- VILTOLARSEN
Indications and Usage
1 INDICATIONS AND USAGE VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. VILTEPSO is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 )