Application Nr Approved Date Route Status External Links
NDA213137 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Oxbryta Is Indicated For The Treatment Of Sickle Cell Disease (Scd) In Adults And Pediatric Patients 12 Years Of Age And Older. This Indication Is Approved Under Accelerated Approval Based On Increase In Hemoglobin (Hb) [See Clinical Studies (14) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trial(S). Oxbryta Is A Hemoglobin S Polymerization Inhibitor Indicated For The Treatment Of Sickle Cell Disease In Adults And Pediatric Patients 12 Years Of Age And Older. This Indication Is Approved Under Accelerated Approval Based On Increase In Hemoglobin (Hb). Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trial(S) ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Voxelotor

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