Mital Patel, PharmD

All articles by Mital Patel, PharmD

Olysio sNDA Submitted for Labeling Update

Janssen Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.

FDA Accepts Ready-to-Use Bivalirudin NDA for Filing

The FDA has accepted for filing the New Drug Application (NDA) for ready-to-use (RTU) bivalirudin (Eagle) for the treatment of patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIa inhibitor; undergoing PCI with, or at risk of heparin-induced thrombocytopenia and thrombosis syndrome; or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).