Entyvio® (vedolizumab)

BL 125476 [BL 761133] [BL 761359]

Entyvio® (vedolizumab)

BL 125476 [BL 761133] [BL 761359]

U.S. License Holder:

Takeda Pharms. USA

Date of License:

May-20-2014 [September-27-2023] [April-18-2024]

Last Update:

June-15-2026

approved_indications FDA-Approved Indications

ENTYVIO (vedolizumab) is an integrin receptor antagonist indicated in adults for the treatment of:

Moderately to severely active ulcerative colitis (UC);

Moderately to severely active Crohn's disease (CD).

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Accepted by FDA

AVT16: Alvotech (June-2026)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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