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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219884
Company: ACADIA PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAYBUE STIX TROFINETIDE 5000MG/PACKET FOR SOLUTION;ORAL Prescription None Yes Yes
DAYBUE STIX TROFINETIDE 6000MG/PACKET FOR SOLUTION;ORAL Prescription None Yes Yes
DAYBUE STIX TROFINETIDE 8000MG/PACKET FOR SOLUTION;ORAL Prescription None Yes Yes
DAYBUE STIX TROFINETIDE 10,000MG SOLUTION; ORAL Prescription None No No
DAYBUE STIX TROFINETIDE 12,000MG SOLUTION; ORAL Prescription None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/11/2025 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219884Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2026 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219884s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219884Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/16/2026 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219884s001lbl.pdf
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