Pelgraz Approval Pending
Pelgraz Approval Pending
U.S. License Holder:
Accord BioPharma
Date of License:
aBLA submitted to FDA on undisclosed date
Last Update:
Nov-15-2024
FDA-Approved IndicationsPelgraz (pegfilgrastim) is not FDA-approved. A BLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / BiosimilarsPelgraz (Accord Healthcare) (September-2018)
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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