FDA Approved Drugs for Gastroenterology

Drugs Approved in 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Drugs Approved in 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012

Gattex (teduglutide); NPS Pharmaceuticals; For the treatment of short bowel syndrome, Approved December 2012

Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 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

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

Drugs Approved in 2011

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 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

Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

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

Drugs Approved in 2010

Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010

Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic insufficiency, Approved April of 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Drugs Approved in 2009

Metozolv ODT (metoclopramide hydrochloride); Salix Pharmaceuticals; For the treatment of gastroesophageal reflux and diabetic gastroparesis, Approved September 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

Cimzia (certolizumab pegol); UCB; For the treatment of Crohn’s disease, Approved April 2008

Entereg (alvimopan); GlaxoSmithKline; For the treatment of postoperative ileus, Approved May 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008

Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohn’s disease, Approved January 2008

Drugs Approved in 2006

Amitiza (lubiprostone); Sucampo/Takeda; For the treatment of chronic idiopathic constipation, Approved January 2006

Drugs Approved in 2005

Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005

Drugs Approved in 2004

Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004

Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004

Drugs Approved in 2003

Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003

Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003

Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003

Drugs Approved in 2002

Aciphex (rabeprazole sodium); Elan Pharmaceuticals; For the treatment of symptomatic gastroesophageal reflux disease, Approved February 2002

Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002

Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas, Approved August 2002

Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002

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

Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved January 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

SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002

Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002

Drugs Approved in 2001

Canasa (mesalamine); Axcan; For the treatment of active ulcerative proctitis, Approved January 2001

Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease, Approved October 2001

Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD, Approved February 2001

Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal reflux disease, Approved March 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 2000

Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative colitis, Approved July 2000

Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000

Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and sour stomach, Approved October 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000

Visicol Tablet; Inkine Pharmaceutical; For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older, Approved September 2000

Drugs Approved in 1999

Prevpac; TAP Pharmaceuticals; Treatment for eradication of H. pylori, Approved February 1999

Drugs Approved in 1998

Cimetidine Hydrochloride Oral Solution; Pharmaceutical Formulations; Generic equivalent of Tagamet HB 200, Approved June 1998

PREVACID(R) (lansopraxole); TAP Pharmaceuticals; Treatment of heartburn associated with GERD, Approved April 1998

Prilosec (omeprazole); Astra Merck; Treatment for heartburn, Approved January 1998

Zantac 75 Efferdose; GlaxoSmithKline; Treatment for heartburn, Approved March 1998

Drugs Approved in 1997

Asacol (mesalamine); Procter & Gamble; Treatment of ulcerative colitis, Approved August 1997

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

Cimetidine Hydrochloride Oral Solution; Hi-Tech Pharmacal; Generic equivalent of Tagamet Oral Solution, 300 mg/5 ml, Approved October 1997

Prevpac; TAP Pharmaceuticals; Treatment for duodenal ulcers, Approved December 1997

Prochloroperazine; Duramed Pharmaceuticals; Generic equivalent of Compazine, Approved May 1997

Ranitidine Capsules; Geneva Pharmaceuticals; Generic equivalent of Zantac GELdose, Approved October 1997

Ranitidine Tablets; Apotex; Generic equivalent of Zantac, Approved September 1997

Urso; Axcan; Treatment for primary biliary cirrhosis, Approved December 1997

Drugs Approved in 1996

Axid AR (nizatidine; Whitehall-Robins Healthcare; Over-the-counter anti-ulcer treatment, Approved May 1996

Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets; Bayer; Treatment for complicated intra-abdominal infections, Approved December 1996

GastroMARK; Advanced Magnetics; Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996

Merrem I.V. (meropenem); AstraZeneca; Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996

Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals; Treatment for vitamin B-12 deficiency, Approved November 1996

Prilosec (omeprazole); Astra Merck; Treatment for heartburn, gastroesophageal reflux disease (GERD), Approved December 1996

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

Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy; Astra Merck, Abbott Laboratories; Treatment for duodenal ulcers, Approved April 1996

Seprafilm; Genzyme; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996

Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996