The FDA issued a Partial Rescission of Approval letter in February 2021, in which the indication for routine prophylaxis in children (<16 years of age) was temporarily rescinded due to its having been granted in error because of a pediatric extension of orphan drug exclusivity held by another product until September 12, 2021.
The BeneFIX庐 indication of routine prophylaxis to reduce the frequency of bleeding episodes in children now has been fully restored. With this change, BeneFIX庐 is indicated for adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes.
An update to the BeneFIX庐 [coagulation factor IX (recombinant)] Prescribing Information can be found at the following link http://labeling.pfizer.com/showlabeling.aspx?id=492.
You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (United States only). If you prefer you may contact the US Food & Drug Administration (FDA) directly at www.fda.gov/Safety/MedWatch or 1-800-FDA-1088.