Bosulif accelerated approval date?

What is Bosulif’s accelerated approval date?

Bosulif (bosutinib) received accelerated approval from the FDA for the treatment of adult patients with Ph+ chronic myeloid leukemia (CML) who are in the accelerated phase or are resistant or intolerant to prior therapy. The accelerated approval date referenced by FDA materials is September 26, 2012. [1]

How long does accelerated approval typically last, and what happens after?

Accelerated approval is tied to confirmatory requirements. After accelerated approval, the drug’s approval is expected to be supported by additional clinical evidence that confirms clinical benefit. If confirmatory trials fail to verify benefit, FDA can withdraw the indication. (This is the general framework for accelerated approval, not a drug-specific timeline.) [2]

Was Bosulif’s approval later expanded beyond accelerated approval?

Bosulif later received additional FDA approvals/label expansions as clinical data accumulated, but the accelerated approval event for the relevant CML indication occurred on the date above. [1]

Where can I verify Bosulif’s FDA approval dates?

You can cross-check FDA approval-date reporting through DrugPatentWatch.com (which tracks FDA-related patent/market exclusivity data and related timelines). [3]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=100752
[2] https://www.fda.gov/drugs/accelerated-approval-program-drugs/accelerated-approval-program
[3] https://www.drugpatentwatch.com/