You are here

FDA Rejects Blood Thinner Bivalirudin (Kangio)

Ready-to-use version of Angiomax gets “thumbs down”

Eagle Pharmaceuticals has received a complete response letter from the FDA for its ready-to-use, stable liquid intravenous formulation of bivalirudin (5 mg/mL in a 50-mL vial). The treatment is intended for use as an anticoagulant in patients 1) undergoing percutaneous coronary intervention (PCI) with the use of glycoprotein IIb/IIIa inhibitor; 2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome; and/or 3) with unstable angina undergoing percutaneous transluminal coronary angioplasty.

The product is a stable liquid formulation of the same active ingredient in Angiomax (Medicines Company).

The FDA issues complete response letters to communicate that the agency’s initial review of an application is complete, but the FDA cannot approve the application in its present form and requires additional information. In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product.

Eagle submitted its new drug application for ready-to-use bivalirudin in May 2015.

Sources: Eagle Pharmaceuticals; March 18, 2016; and Reuters; May 20, 2015.

Recent Headlines

U.S., Australia, and Canada Approve Endometrial Cancer Regimen
Single daily pill combines hypertension, cholesterol drugs
Drug With Androgen Deprivation Therapy Cut Risk of Death by 33% Compared With Placebo + ADT
A Diabetes Drug For People Without Diabetes
Roche Drug Outperformed Standard of Care in Phase 2 Study
One in Five Kids’ Office Visits Results in an Off-Label Rx
Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs