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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761068
Company: KYOWA KIRIN

Products on BLA 761068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CRYSVITA	BUROSUMAB-TWZA	10MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761068s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761068s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761068Orig1s005ltr.pdf
09/27/2019	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761068s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761068Orig1s004ltr.pdf
09/27/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761068s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761068Orig1s003ltr.pdf

Labels for BLA 761068

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2020	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761068s005lbl.pdf
09/27/2019	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761068s004lbl.pdf
09/27/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761068s003lbl.pdf
04/17/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761068s000lbl.pdf

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