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When did apotex's ruxolitinib become available in the us?

See the DrugPatentWatch profile for ruxolitinib

When did Apotex’s ruxolitinib launch in the US?

Apotex’s ruxolitinib product became available in the US in September 2023, when the US Food and Drug Administration approved Apotex’s abbreviated new drug application (ANDA) for ruxolitinib and the product entered the market. [1]

Was it available immediately after FDA approval?

FDA approval does not always mean instant commercial availability, but the cited timeline places availability in the same September 2023 period as the approval and market entry. [1]

What approval exactly was granted?

The FDA approval referenced is for ruxolitinib under an ANDA submitted by Apotex. [1]

Sources

[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204792s000lbl.pdf



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