TVB-009P Approval Pending
TVB-009P Approval Pending
U.S. License Holder:
Teva
Date of License:
aBLA accepted by FDA October-2024
Last Update:
Nov-30-2025
FDA-Approved IndicationsTVB-009P (denosumab) is not FDA-approved. An aBLA has been accepted by the FDA.
Approved Foreign Follow-On Biologics / BiosimilarsPonlimsi / Degevma (Teva) (November-2025)
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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