FDA Alerts
FDA Expands Label for Daklinza
On February 5, 2016, FDA approved changes to the DAKLINZA(daclatasvir) label to expand the indication to include HCV genotype 1 infection and expand dosage recommendations to the following populations and to revise dosage recommendations for HCV genotype 3 subjects with compensated (Child-Pugh A) cirrhosis:
FDA OKs New Hep C Rx
The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
Uptravi Approved for Pulmonary Arterial Hypertension (PAH)
The U.S. Food and Drug Administration today approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
Type 2 Diabetes Rx May Pose Serious Health Risks
An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections.
First Flu Vaccine with Adjuvant Approved
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
Combo HIV Tablet Approved
The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
FDA Investigates Outbreak Tied to Cucumbers
The FDA, CDC, and state and local officials are investigating a multistate outbreak of Salmonella Poona linked to “slicer” cucumbers, supplied by Andrew and Williamson Fresh Produce and grown in Baja, Mexico.
Hep C Type 3 Treatment Approved
The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.
FDA Approves Novel Hep C Rx
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
FDA Approves Rx for Rare Lung Disease
The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.