ULTRAGENYX

ULTRAGENYX

approved_indications FDA Approved Biologics and Pending Applications

Crysvita®

burosumab-twza
BL 761068

Mepsevii®

vestronidase alfa-vjbk
BL 761047

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – April 2018 April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D. May 3, 2018

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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