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New Drug Application (NDA): 213535
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVRYSDI RISDIPLAM 0.75MG/ML FOR SOLUTION;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
08/07/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213535s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213535Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213535Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2022 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s006ltr.pdf
05/27/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s003, s005ltr.pdf
05/27/2022 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s003, s005ltr.pdf
04/30/2021 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213535s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213535Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/27/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf
05/27/2022 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf
03/21/2022 SUPPL-6 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535Orig1s006lbl.pdf
04/30/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213535s001lbl.pdf
08/07/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213535s000lbl.pdf
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