GP2411 (denosumab)

GP2411 Approval Pending

GP2411 (denosumab)

GP2411 Approval Pending

U.S. License Holder:

Sandoz

Date of License:

aBLA accepted by FDA February-2023

Last Update:

March-23-2023

approved_indications FDA-Approved Indications

GP2411 (denosumab) is not FDA-approved. An aBLA has been accepted by the FDA.

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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