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View By:YearCompanyConditionsTherapeutic AreasDrug Names

FDA Approved Drugs by Therapeutic Area

Search by therapeutic area for drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Click on an area below to view the complete list of drugs in that category or review descriptions for our therapeutic area list to assist you in your search.

Find out more about the types of drugs included in this listing.

FDA Approved Drugs for Gastroenterology

Drugs Approved in 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014

Drugs Approved in 2013

Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 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