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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216718
Company: REATA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SKYCLARYS OMAVELOXOLONE 50MG CAPSULE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2023 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216718Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216718Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216718Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2024 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216718Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/25/2024 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s002lbl.pdf
01/25/2024 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s002lbl.pdf
02/28/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216718Orig1s000lbl.pdf
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