Approved Drugs for Gastroenterology

Drugs Approved in 2008

• Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008
• Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn’s disease; Biogen IDEC; Approved January 2008

Drugs Approved in 2007

Drugs Approved in 2006

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

Drugs Approved in 2005

Drugs Approved in 2004

• Avastin (bevacizumab); For the treatment of metastatic carcinoma of the colon or rectum; Genentech; Approved February 2004
• Erbitux (cetuximab); For the treatment of EGFR-expressing, metastatic colorectal cancer; Imclone, Bristol-Myers Squibb; Approved February 2004

Drugs Approved in 2003

• Aloxi (palonosetron); For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy; MGI Pharma, Helsinn Healthcare; Approved August 2003
• Emend (aprepitant); For the treatment of nausea and vomiting associated with chemotherapy; Merck; Approved March 2003
• Oxytrol (oxybutynin transdermal system); For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.; Watson Pharmaceuticals; Approved March 2003

Drugs Approved in 2002

• Aciphex (rabeprazole sodium); For the treatment of symptomatic gastroesophageal reflux disease; Eisai; Approved February 2002
• Alinia (nitazoxanide); For the treatment Diarrhea caused by Cryptosporidium and Giardia in children.; Romark Laboratories; December 2002
• Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); For the treatment of colon or rectum carcinomas; Sanofi-Synthelabo; Approved August 2002
• Gleevec (imatinib mesylate); For the treatment of gastrointestinal stromal tumors (GISTs); Novartis; Approved February 2002
• Hepsera (adefovir dipivoxil); For the treatment of chronic hepatitis B in adults with evidence of active viral replication; Gilead Sciences; Approved September 2002
• Orfadin (nitisinone); Capsules for the treatment of hereditary tyrosinemia type I; Orphan Pharmaceuticals; Approved January 2002
• Pegasys (peginterferon alfa-2a); For the treatment of chronic hepatitis C who have compensated liver disease; Roche; Approved October 2002
• Protonix (pantoprazole sodium) Delayed Release Tablets; Oral tablets for the treatment of gastroesophageal and pathological hypersecretory conditions; Wyeth Pharmaceuticals; Approved April 2002
• SecreFlo (secretin); To aid in the diagnosis of pancreatic dysfunction and gastrinoma; Repligen; Approved April 2002
• Zelnorm (tegaserod maleate) Tablets; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation; Novartis; Approved July 2002
• Zelnorm (tegaserod maleate) Tablets; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation; Novartis; Approved July 2002

Drugs Approved in 2001

• Canasa (mesalamine); For the treatment of active ulcerative proctitis; Axcan Scandipharm; Approved January 2001
• Entocort EC (budesonide); Capsules for the treatment of mild-to-moderate, active Crohn's disease; AstraZeneca; Approved October 2001
• Nexium (esomeprazole magnesium); For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD; AstraZeneca; Approved February 2001
• Protonix (pantoprazole sodium) Intravenous Formulation; For the short-term treatment of gastroesophageal reflux disease; Wyeth-Ayerst Laboratories; Approved March 2001
• Rebetol (ribavirin); For the treatment of chronic hepatitis C; Schering-Plough; Approved July 2001
• Twinrix; For the prevention of hepatitis A and B; GlaxoSmithKline; Approved May 2001

Drugs Approved in 2000

• Colazal (balsalazide disodium); Mild to moderately active ulcerative colitis; SALIX PHARMACEUTICALS; Approved July 2000
• Lotronex (alosetron HCL) Tablets; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS; GlaxoWellcome; Approved February 2000
• Pepcid Complete; For use in the relief of heartburn associated with acid indigestion and sour stomach; Merck; Approved October 2000
• Protonix (pantoprazole sodium) Delayed-Release Tablets; For treatment of erosive esophagitis; Wyeth-Ayerst Laboratories; Approved February 2000
• Visicol Tablet; For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older; Inkine Pharmaceutical; Approved September 2000

Drugs Approved in 1999

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

Drugs Approved in 1998

• Cimetidine; Generic equivalent of Tagamet HB 200; Pharmaceutical Formulations; Approved June 1998
• PREVACID(R) (lansopraxole); Treatment of heartburn associated with GERD; TAP Pharmaceuticals; Approved April 1998
• Prilosec; Treatment for heartburn; Astra Merck; Approved January 1998
• Zantac 75 Efferdose; Treatment for heartburn; GlaxoWellcome; Approved March 1998

Drugs Approved in 1997

• Asacol (mesalamine); Treatment of ulcerative colitis; Procter & Gamble; Approved August 1997
• Cimetadine Hydrochloride Oral Solution 300mg/5ml; Generic equivalent of Tagamet Oral Solution; Morton Grove Pharmaceuticals; Approved October 1997
• Cimetidine Hydrochloride Oral Solution; Generic equivalent of Tagamet Oral Solution, 300 mg/5 ml; Hi-Tech Pharmacal; Approved October 1997
• Prevpac; Treatment for duodenal ulcers; TAP Pharmaceuticals; Approved December 1997
• Prochloroperazine; Generic equivalent of Compazine; Duramed Pharmaceuticals; Approved May 1997
• Ranitidine Capsules; Generic equivalent of Zantac GELdose; Geneva Pharmaceuticals; Approved October 1997
• Ranitidine Tablets; Generic equivalent of Zantac; Apotex; Approved September 1997
• Urso; Treatment for primary biliary cirrhosis; Axcan Schwarz; Approved December 1997

Drugs Approved in 1996

• Axid AR (nizatidine; Over-the-counter anti-ulcer treatment; Whitehall-Robins Healthcare; Approved May 1996
• Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets; Treatment for complicated intra-abdominal infections; Bayer; Approved December 1996
• GastroMARK; Contrast agent for magnetic resonance imaging of the gastrointestinal tract; Advanced Magnetics; Approved May 1996
• Merrem I.V. (meropenem); Treatment for intra-abdominal infections and bacterial meningitis; Zeneca Pharmaceuticals; Approved June 1996
• Nascobal Gel (Cyanocobalamin, USP); Treatment for vitamin B-12 deficiency; Questcor Pharmaceuticals; Approved November 1996
• Prilosec (omeprazole); Treatment for heartburn, gastroesophageal reflux disease (GERD); Astra Merck; Approved December 1996
• Prilosec (omeprazole); Treatment for gastric ulcers; Astra Merck; Approved March 1996
• Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy; Treatment for duodenal ulcers; Astra Merck, Abbott Laboratories; Approved April 1996
• Seprafilm; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery; Genzyme; Approved August 1996
• Visipaque (iodixanol); Diagnostic contrast agent; Nycomed; Approved April 1996

Drugs Approved in 1995