After a couple of misfires, Pfizer has finally won FDA approval for its biosimilar of anemia drug Epogen/Procrit, a drug whose U.S. sales generated about $1.8 billion last year for partners Amgen and ...
Please provide your email address to receive an email when new articles are posted on . The FDA today approved epoetin alfa-epbx, the first epoetin alfa biosimilar, for the treatment of anemia caused ...
Dec. 2, 2005 -- The US Food and Drug Administration (FDA), Amgen Inc, and Ortho Biotech Clinical Affairs, LLC, have notified healthcare professionals via letter regarding revisions to the safety ...
The US Food and Drug Administration (FDA) has approved the first biosimilar erythropoiesis-stimulating agent. The reference product is epoetin alfa (Epogen/Procrit, Amgen). The new biosimilar is ...
On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed ...
The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar. But the win in court for Pfizer subsidiary ...
The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and ...
The anemia drugs epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) are among the top-sellers in the U.S., as consumers and their insurance companies spent $7.2 billion in 2008 on this ...