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.
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 Viekira Pak to Treat Hepatitis C
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
FDA Approves First Combination Pill to Treat Hepatitis C
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
FDA Approves Sovaldi for Chronic Hepatitis C
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection.
FDA Approves New Treatment for Hepatitis C Virus
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
FDA Approves First Genotyping Test for Patients with Hepatitis C Virus
The US Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying.
Victrelis and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis ( boceprevir ), a hepatitis C virus ( HCV ) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time.
Because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz ( atazanavir ), ritonavir-boosted Prezista ( darunavir ), and Kal...