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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761090
Company: DYAX CORP.

Products on BLA 761090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAKHZYRO	LANADELUMAB-FLYO	300MG/2ML (150MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No
TAKHZYRO	LANADELUMAB-FLYO	300MG/2ML (150MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761090Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761090Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761090s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761090Orig1s010ltr.pdf
02/08/2022	SUPPL-3	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761090s003lbl.pdf
11/16/2018	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761090Orig1s001ltr.pdf

Labels for BLA 761090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761090s010lbl.pdf
02/08/2022	SUPPL-3	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761090s003lbl.pdf
11/16/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf
11/16/2018	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf
08/23/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf

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