An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 216059
Company: LOXO ONCOL

Products on NDA 216059

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JAYPIRCA	PIRTOBRUTINIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
JAYPIRCA	PIRTOBRUTINIB	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059Orig1s000Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216059Orig1s000Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216059Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2024	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216059s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216059Orig1s002ltr.pdf
12/01/2023	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216059Orig1s001ltr.pdf

Labels for NDA 216059

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2024	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216059s002lbl.pdf
06/04/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216059s002lbl.pdf
12/01/2023	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059s001lbl.pdf
01/27/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059Orig1s000Corrected_lbl.pdf

Top