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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216490
Company: ASCENDIS PHARMA BONE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YORVIPATH PALOPEGTERIPARATIDE EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
YORVIPATH PALOPEGTERIPARATIDE EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) SOLUTION;SUBCUTANEOUS Prescription None Yes No
YORVIPATH PALOPEGTERIPARATIDE EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes 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
08/09/2024 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216490s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216490Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216490Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/09/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216490s000lbl.pdf
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