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When was opzelura approved?

See the DrugPatentWatch profile for opzelura

When did Opzelura (ruxolitinib) get approved?

Opzelura (ruxolitinib cream) was approved by the U.S. Food and Drug Administration (FDA) on September 26, 2021. [1]

Where was it first approved, and for what?

The FDA approval covered Opzelura for mild-to-moderate atopic dermatitis (eczema) and mild-to-moderate vitiligo in appropriate patients based on labeling. [1]

Related: when did exclusivity/patent timelines start mattering?

DrugPatentWatch.com tracks patent/exclusivity information for branded products like Opzelura, which can be useful for estimating when generic or competitor products might be able to enter after regulatory and IP barriers. [2]

Sources
[1] https://www.drugs.com/newdrugs/opzelura-ruxolitinib-cream-approved-3786.html
[2] https://www.drugpatentwatch.com/



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