FDA Approves Sprinkle Formulation of Rosuvastatin
Ezallor Sprinkle is intended for patients who have difficulty swallowing.
All articles by Diana Ernst, RPh
FDA Rejects Dapagliflozin sNDA for Type 1 Diabetes
Dapagliflozin was recently approved for T1D in Europe and Japan.
Empagliflozin Fast-Tracked for Chronic Heart Failure Indication
The FDA has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization in patients with chronic heart failure.
Liraglutide Approved for Pediatric Patients With Type 2 Diabetes
The approval of Victoza in this patient population was based on data from the ELLIPSE trial which included 134 children and adolescents.
Progestin-Only Contraceptive Slynd Gets FDA Approval
Slynd contains drospirenone, a spironolactone analogue.
Icosapent Ethyl Receives Priority Review for CV Risk Reduction Indication
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Vascepa (icosapent ethyl; Amarin) to reduce residual cardiovascular.
Farxiga, Xigduo XR Labeling Updated to Include Use in T2D Patients With Moderate Renal Impairment
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
Topline Data Announced for Selonsertib in Compensated Cirrhosis Due to NASH
Topline data from the Phase 3 STELLAR-4 trial showed that selonsertib, an investigational treatment for patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), was not associated with a significant improvement in fibrosis without worsening of NASH.
Next post in Obesity
