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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761163
Company: MORPHOSYS US INC

Products on BLA 761163

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONJUVI	TAFASITAMAB-CXIX	12MG/KG	SOLUTION;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761163

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761163s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761163Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2025	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761163Orig1s013ltr.pdf
06/02/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761163s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761163Orig1s001ltr.pdf

Labels for BLA 761163

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2025	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdf
06/02/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761163s001lbl.pdf
06/02/2021	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761163s001lbl.pdf
07/31/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761163s000lbl.pdf

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