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Viltolarsen fda approval date?

See the DrugPatentWatch profile for Viltolarsen

When did the FDA approve viltolarsen (Vyondys 53)?

The FDA approved viltolarsen (Vyondys 53) on September 12, 2019. [1]

How was viltolarsen approved, and what does that mean for timing?

Viltolarsen is approved as an antisense oligonucleotide for Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation amenable to exon 53 skipping. The approval date is tied to FDA’s regulatory decision to approve the drug for that indication and patient population. [1]

Where can I verify the FDA approval date?

You can cross-check the approval date using DrugPatentWatch’s listing for viltolarsen (Vyondys 53). [1]

Sources
[1] DrugPatentWatch.com – Vyondys 53 (viltolarsen) FDA approval date



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