FDA Approved Drugs for Hepatology (Liver, Pancreatic, Gall Bladder)

Drugs Approved in 2017

Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Drugs Approved in 2016

Defitelio (defibrotide sodium); Jazz Pharmaceuticals; For the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following HSCT, Approved March 2016

Ocaliva (obeticholic acid); Intercept Pharmaceuticals; For the treatment of primary biliary cholangitis, Approved May 2016

Vemlidy (tenofovir alafenamide); Gilead Sciences; For the treatment of chronic hepatitis B , Approved November 2016

Zepatier (elbasvir and grazoprevir); Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016

Drugs Approved in 2015

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015

Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015

Drugs Approved in 2013

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013

Drugs Approved in 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Drugs Approved in 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Incivek (telaprevir); Vertex Pharmaceuticals; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Drugs Approved in 2010

Cayston (aztreonam for inhalation solution); Gilead; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Drugs Approved in 2009

Afinitor (everolimus); Novartis; For the treatment of renal cell carcinoma, Approved March 2009

Avastin (bevacizumab); Genentech; For the treatment of renal cell carcinoma, Approved July 2009

Votrient (pazopanib); GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved October of 2009

Zenpep (pancrelipase); Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis or other conditions, Approved August 2009

Drugs Approved in 2008

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Drugs Approved in 2007

Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007

Drugs Approved in 2006

Tyzeka (telbivudine); Idenix Pharma; For the treatment of hepatitis B virus, Approved October 2006

Drugs Approved in 2005

Baraclude (entecavir); Bristol-Myers Squibb; For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 2005

Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved December 2005

Drugs Approved in 2004

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli, Approved May 2004

Drugs Approved in 2002

Hepsera (adefovir dipivoxil); Gilead; For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002

Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002

Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002

Protonix (pantoprazole sodium) Delayed Release Tablets; Wyeth; Oral tablets for the treatment of gastroesophageal and pathological hypersecretory conditions, Approved April 2002

Drugs Approved in 2001

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Drugs Approved in 1998

Pulmozyme (dornase alfa); Genentech; Treatment for cystic fibrosis, Approved March 1998

REBETRON (TM) Combination Therapy; Schering-Plough; Treatment for Chronic Hepatitis C, Approved June 1998

Drugs Approved in 1997

Cimetadine Hydrochloride Oral Solution 300mg/5ml; Morton Grove Pharmaceuticals; Generic equivalent of Tagamet Oral Solution, Approved October 1997

Galzin (zinc acetate); Teva Pharmaceutical; Treatment for Wilson’s disease, Approved January 1997

INFERGEN (interferon alfacon-1); Amgen; Treatment for chronic hepatitis C virus, Approved October 1997

Intron A (interferon alfa-2b, recombinant); Schering-Plough; Treatment for hepatitis C, Approved March 1997

Tobi; PathoGenesis; Treatment for cystic fibrosis, Approved December 1997

Drugs Approved in 1996

Feridex I.V.; Advanced Magnetics; Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996

Havrix; SmithKline Beecham; Treatment for hepatitis A, Approved March 1996

Prilosec (omeprazole); Astra Merck; Treatment for gastric ulcers, Approved March 1996

Pulmozyme (dornase alfa); Genentech; Treatment for cystic fibrosis patients with advanced disease, Approved December 1996

Zithromax (azithromycin); Pfizer; Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection, Approved June 1996