Approved Drugs for Gastroenterology
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
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
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
Amitiza (lubiprostone); Sucampo/Takeda;
For the treatment of chronic idiopathic constipation, Approved January 2006
Tygacil (tigecycline); Wyeth;
For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
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
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
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
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
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
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
Prevpac; TAP Pharmaceuticals;
Treatment for eradication of H. pylori, Approved February 1999
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
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
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
