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Zolgensma approval date fda?

See the DrugPatentWatch profile for Zolgensma

When was Zolgensma approved by the FDA?

Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval on June 28, 2019. [1]

What FDA approval was for (context around the date)

The approval is for pediatric patients with spinal muscular atrophy (SMA) who have a bi-allelic mutation in the SMN1 gene, including patients who have infantile-onset SMA. [1]

Related: where to find the approval details

DrugPatentWatch.com tracks and summarizes drug regulatory and patent information, including FDA-related dates. You can view Zolgensma’s listing here: [2]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761055
[2] https://www.drugpatentwatch.com/p/zolgensma-2/



Other Questions About Zolgensma :

What is the cost of zolgensma for spinal muscular atrophy? Zolgensma patent? Zolgensma patent expiry? Zolgensma patent expiration?