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Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies

The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.
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Invokana Approved to Slow Progression of Diabetic Nephropathy in T2D Patients

The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.
Drugs in the Pipeline

Invokana Gets FDA’s Priority Review for CKD in T2D Indication

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
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Zulresso Approved as First Treatment for Postpartum Depression

The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…
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Vemlidy Labeling Updated With Dosing Info for Patients With ESRD

The Food and Drug Administration (FDA) has approved a labeling update for Vemlidy (tenofovir alafenamide; Gilead Sciences) to include dosage information regarding its use in adults with end-stage renal disease (ESRD; CrCl <15mL/min) who are receiving chronic hemodialysis.