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.
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.
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 Test for Group of Human Retroviruses
The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II).
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 New Rx for Combination with Other HIV Medications
On September 24, 2014, FDA approved Vitekta (elvitegravir) 85 mg and 150 mg tablets.
FDA Approves New Rx for Combination with HIV Medications
On September 24, 2014, FDA approved Tybost (cobicistat) 150 mg tablets. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.