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New Drug Approvals June - August 2016 Name & Dose Form Manufacturer Indication Date Approved Average Wholesale Price Projected US Sales Rayaldee ER capsules OPKP Health, Inc. Secondary Hyperparathyroidism 06/17/16 Not available at the current time $72 million annually...read more
New Drug Approvals March - June 2016 Name Manufacturer Indication Date Approved Average Wholesale Price Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) Gilead Sciences, Inc. HIV March 1, 2016 $2,815 per 30 days Kovaltry (antihemophilic factor) Bayer...read more
On June 28, 2016, FDA approved Gilead’s new drug, Epclusa, to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin.read more