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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219285
Company: GENENTECH INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVRYSDI RISDIPLAM 5MG TABLET;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
02/11/2025 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219285s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219285Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219285Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2026 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535Orig1s017;219285Orig1s002correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213535Orig1s017;219285Orig1s002correctedltr.pdf
01/21/2026 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219285s001,213535s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219285Orig1s001,213535Orig1s016ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/10/2026 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535Orig1s017;219285Orig1s002correctedlbl.pdf
02/10/2026 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535Orig1s017;219285Orig1s002correctedlbl.pdf
01/21/2026 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219285s001,213535s016lbl.pdf
02/11/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219285s000lbl.pdf
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