Spinraza approval date?

When was Spinraza (nusinersen) first approved?

Spinraza (nusinersen) received its first FDA approval on December 23, 2016. [1]

Was Spinraza approved earlier or later outside the US?

The earliest approval date varies by country and regulator. For the most direct, date-specific answer for the US, use the FDA approval date above. [1]

What does “approval date” usually mean for Spinraza?

For most users asking this, “approval date” refers to the regulator’s first authorization to market the drug in a given country (for example, the initial FDA approval date in the US). [1]

Source for more approval and exclusivity details

DrugPatentWatch tracks branded drug history and related regulatory/patent context and can be used to cross-check timeline details: https://www.drugpatentwatch.com/p/spinraza/ [2]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205365
[2] https://www.drugpatentwatch.com/p/spinraza/