Approved Drugs for Immunology/Infectious Diseases

Drugs Approved in 2008

• Aptivus (tipranavir); For the treatment of HIV; Boehringer Ingelheim; Approved June 2008
• Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
• Intelence (etravirine); For the treatment of HIV-1; Tibotec; Approved January 2008
• Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 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
• Viread (tenofovir disoproxil fumarate); For the treatment of hepatitis B; Gilead; Approved August 2008
• Viread (tenofovir disoproxil fumarate); For the treatment of hepatitis B; Gilead; Approved August 2008

Drugs Approved in 2007

• Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
• AzaSite (azithromycin); For the treatment of bacterial conjunctivitis; InSite Vision; Approved April 2007
• Doribax (doripenem); For the treatment of intra-abdominal infections and urinary tract infections; Johnson & Johnson; Approved October 2007
• Extina (ketoconazole); For the treatment of seborrheic dermatitis; Stiefel; Approved June 2007
• Isentress (raltegravir); For the treatment of HIV-1; Merck; Approved October 2007
• Selzentry (maraviroc); For the treatment of CCR5-tropic HIV-1; Pfizer; Approved August 2007
• Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
• Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Drugs Approved in 2006

• Eraxis (anidulafungin); For the treatment of Candida fungal infections; Pfizer; Approved February 2006
• Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); For the prevention of cervical cancer associated with human papillomavirus; Merck; Approved June 2006
• Noxafil (posaconazole); For the treatment of fungal infections; Schering; Approved in September 2006
• Prezista (darunavir); For the treatment of treatment-resistant HIV infections; Tibotec; Approved June 2006
• Rotateq (rotavirus vaccine, live oral pentavalent); For the prevention of gastroenteritis associated with rotavirus infections in infants; Merck; Approved February 2006
• Tyzeka (telbivudine); For the treatment of hepatitis B virus; Idenix Pharma; Approved October 2006
• Veregen (kunecatechins); For the treatment of external genital and perianal warts; Medigene; Approved October 2006

Drugs Approved in 2005

• Aptivus (tipranavir); For the adjunctive treatment of HIV-1 infections; Boehringer Ingelheim; Approved June, 2005
• Baraclude (entecavir); For the treatment of chronic hepatitis B infections with evidence of active viral replication; Bristol-Myers Squibb; Approved March, 2005

Drugs Approved in 2004

• Ketek (telithromycin); For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia.; Aventis Pharmaceuticals; Approved April 2004
• Tindamax, tinidazole; For the treatment of microbial infections, including trichomoniasis, giardiasis, and amebiasis; Presutti Laboratories; Approved May, 2004
• Xifaxan (rifaximin); For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli; Salix Pharmaceuticals; Approved May 2004

Drugs Approved in 2003

• Amevive (alefacept); For moderate to severe chronic plaque psoriasis.; Biogen; Approved January 2003
• FluMist ( Influenza Virus Vaccine); For the prevention of disease caused by influenza A and B viruses; MedImmune; Approved June 2003
• Fuzeon (enfuvirtide); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Trimeris, Roche; Approved March 2003
• Lexiva (fosamprenavir calcium); For the treatment of HIV infection in adults in combination with other antiretroviral agents.; GlaxoSmithKline; Approved October 2003
• Reyataz (atazanavir sulfate); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Bristol-Myers Squibb; Approved July 2003

Drugs Approved in 2002

• Alinia (nitazoxanide); For the treatment Diarrhea caused by Cryptosporidium and Giardia in children.; Romark Laboratories; December 2002
• Clarinex; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria; Schering-Plough; Approved February 2002
• Daptacel; Pediatric vaccine for immunization against diptheria, tetanus and pertussis; Aventis Pasteur; Approved May 2002
• Fluzone Preservative-free; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants; Aventis Pasteur; Approved September 2002
• Hepsera (adefovir dipivoxil); For the treatment of chronic hepatitis B in adults with evidence of active viral replication; Gilead Sciences; Approved September 2002
• Pediarix Vaccine; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old.; GlaxoSmithKline; Approved December 2002
• Pegasys (peginterferon alfa-2a); For the treatment of chronic hepatitis C who have compensated liver disease; Roche; Approved October 2002
• Restasis (cyclosporine ophthalmic emulsion); For the treatment of low tear production.; Allergan; December 2002
• Sustiva; Once-daily oral tablet for the the treatment of HIV infection; Bristol-Myers Squibb; Approved February 2002
• Vfend (voriconazole); For the treatment of fungal infections; Pfizer; Approved May 2002

Drugs Approved in 2001

• Avelox I.V. (moxifloxacin hydrochloride); Injectable antibacterial agent for adults with susceptible strains of bacterial infections; Bayer; Approved November 2001
• Cancidas; Intravenous infusion for the treatment of invasive aspergillosis; Merck; Approved January 2001
• Peg-Intron (peginterferon alfa-2b); For the treatment of chronic hepatitis C; Schering-Plough; Approved January 2001
• Rebetol (ribavirin); For the treatment of chronic hepatitis C; Schering-Plough; Approved July 2001
• Spectracef; Oral tablets for the treatment of mild to moderate bacterial infections; TAP Pharmaceuticals; Approved August 2001
• Twinrix; For the prevention of hepatitis A and B; GlaxoSmithKline; Approved May 2001
• Valcyte (valganciclovir HCl); For the treatment of cytomegalovirus retinitis in patients with AIDS; Roche; Approved March 2001
• Viread; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection; Gilead Sciences; Approved October 2001
• Xigris (drotrecogin alfa [activated]); For the treatment of severe sepsis; Eli Lilly; Approved November 2001

Drugs Approved in 2000

• ABREVA (docosanol); Cold sore/fever blister; AVANIR PHARMACEUTICALS; Approved July 2000
• Biaxin XL (clarithromycin extended-release tablets); For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis; Abbott Laboratories; Approved March 2000
• Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
• Children's Motrin Cold; For temporary relief of the common cold; McNeil Consumer Products; Approved August 2000
• Evoxac; For the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome; SnowBrand Pharmaceuticals; Approved January 2000
• Kaletra Capsules and Oral Solution; For the treatment of HIV-1 infection; Abbott Laboratories; Approved September 2000
• Lamisil (terbinafine hydrochloride) Solution, 1%; For the treatment of athlete's foot, jock itch and ringworm; Novartis; Approved March 2000
• Lotrisone (clotrimazole/betamethasone diproprionate) lotion; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis; Schering-Plough; Approved December 2000
• Malarone (atovaquone; proguanil hydrochloride) Tablet; For the treatment and prevention of Plasmodium falciparum malaria; GlaxoWellcome; Approved July 2000
• Rapamune (sirolimus) Tablets; For treatment of kidney rejection; Wyeth-Ayerst Laboratories; Approved August 2000
• Rid Mousse; For the treatment of head, pubic (crab), and body lice; Soltec Research; Approved March 2000
• Tri-Nasal Spray (triamcinolone acetonide spray); For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older; Muro Pharmaceutical; Approved February 2000
• Trivagizole 3 (clotrimazole) Vaginal Cream; For the treatment of vaginal yeast infections; Taro Pharmaceuticals; Approved April 2000
• Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; For the treatment of HIV-1 infection; GlaxoWellcome; Approved November 2000

Drugs Approved in 1999

• Agenerase (amprenavir); For the treatment of HIV-1 infection.; GlaxoWellcome; Approved April 1999
• Cleocin; Treatment for bacterial vaginosis; Pharmacia & Upjohn; Approved August 1999
• Famvir; Treatment for Herpes Simplex Infections in HIV-infected patients; SmithKline Beecham; Approved January 1999
• Norvir (ritonavir) soft-gel capsules; Treatment for HIV infection; Abbott Laboratories; Approved June 1999
• Panretin Gel; Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.; Ligand Pharmaceuticals; Approved June 1999
• Rapamune; Oral solution of sirolimus; Wyeth-Ayerst Laboratories; Approved September 1999
• Relenza; Treatment for uncomplicated acute illness due to influenza virus; GlaxoWellcome; Approved July 1999
• Synercid I.V.; quinupristin and dalfopristin for injection; Rhone Poulenc Rorer; Approved September 1999
• Tamiflu capsule; Oseltamivir phosphate capsule; Roche; October 27, 1999
• Vistide; For the treatment of cytomegalovirus (CMV) retinitis; Gilead Sciences; Approved March 1999

Drugs Approved in 1998

• Allegra-D; Treatment for nasal congestion due to seasonal allergy; Hoechst Marion Roussel; Approved March 1998
• CellCept; Treatment for the prevention of organ rejection inpatients undergoing heart transplants; Roche; Approved February 1998
• Clemastine fumarate syrup; Generic equivalent of Tavist Syrup; Morton Grove Pharmaceuticals; Approved March 1998
• Cleocin Vaginal Cream 2%; Treatment for bacterial vaginosis; Pharmacia & Upjohn; Approved March 1998
• Dynabac; Treatment for acute bacterial exacerbations (chronic bronchitis and skin infections); Sanofi Pharmaceuticals; Approved March 1998
• REBETRON (TM) Combination Therapy; Treatment for Chronic Hepatitis C; Schering-Plough; Approved June 1998
• Simulect; Treatment for acute organ transplant rejection; Novartis; Approved May 1998
• Timentin; Treatment for wide range of infections in children; SmithKline Beecham; Approved January 1998
• Viroptic; Treatment for inflammation of the cornea in children due to herpes simplex virus; King Pharmaceuticals; Approved February 1998

Drugs Approved in 1997

• INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); Treatment for diphtheria, tetanus and pertussis (whooping cough) in infants and children; SmithKline Beecham; January 1997
• Acyclovir Capsules; Generic equivalent of Zovirax; Teva Pharmaceutical; Approved April 1997
• Aldara (imiquimod); Treatment for external genital and perianal warts; 3M Pharmaceuticals; Approved March 1997
• Aphthasol; Treatment for canker sores; Block Drug Company; Approved December 1997
• Combivir; Treatment for AIDS and HIV Infection; GlaxoWellcome; Approved September 1997
• Condylox Gel 0.5% (pokofilox); Treatment for external genital and perianal warts; Oclassen Pharmaceuticals; Approved March 1997
• Famvir (famciclovir); Treatment for genital herpes; SmithKline Beecham; Approved September 17, 1997
• Flagyl ER; Treatment for bacterial vaginosis; Searle; Approved December 1997
• Flonase Nasal Spray; Treatment for seasonal and perennial allergic rhinitis; GlaxoWellcome; Approved November 1997
• Fortovase; Treatment for HIV infection; Roche; Approved November 1997
• INFERGEN (interferon alfacon-1); Treatment for chronic hepatitis C virus; Amgen; Approved October 1997
• INTRON A (Interferon alfa-2b, recombinant); Treatment for hepatitis C; Schering-Plough; Approved March 1997
• Rescriptor Tablets (delavirdine mesylate tablets); Treatment for HIV-1 infection; Pharmacia & Upjohn; Approved April 1997
• SPORANOX (itraconazole); Treatment for oral thrush; Janssen Pharmaceutica; Approved March 1997
• Stromectol (ivermectin); Treatment for nondisseminated intestinal threadworm; Merck; Approved March 1997
• Taxol; Treatment for AIDS-related Kaposi's Sarcoma; Bristol-Myers Squibb; Approved August 1997
• Trovan; Treatment for bacterial infections; Pfizer; Approved December 1997
• VIRACEPT (nelfinavir mesylate); Treatment for HIV infection in adults and children; Agouron Pharmaceuticals; Approved March 1997
• Zerit (stavudine, d4T); Treatment for infants and children infected with HIV; Bristol-Myers Squibb; Approved January 1997

Drugs Approved in 1996

• Albenza (albendazole); Treatment for parasitic infections caused by worms; SmithKline Beecham; Approved June 1996
• Apthasol (Amlexanox); Treatment for canker sores; Access Pharmaceuticals; Approved May 1996
• Carrington patch; Treatment for canker sores; Carrington Laboratories; Approved May 1996
• Confide; HIV testing and counseling service; Johnson & Johnson; Approved May 1996
• Crixivan (Indinavir sulfate); Treatment for HIV infection; Merck; Approved March 1996
• Gastrocrom Oral Concentrate (cromolyn sodium); Treatment for mastocytosis; Rhone Poulenc Rorer; Approved April 1996
• Havrix; Treatment for hepatitis A; SmithKline Beecham; Approved March 1996
• Lamisil (terbinafine hydrochloride) Tablets; Treatment for nail fungal infections; Sandoz Pharmaceuticals; Approved May 1996
• Leukine (sargramostim); Treatment for the replenishment of white blood cells; Immunex; Approved November 1996
• Norvir (ritonavir); Treatment for HIV infection; Abbott Laboratories; Approved March 1996/March 1997
• Oral Cytovene; Treatment for the prevention of cytomegalovirus (CMV); Roche; Approved December 1996
• RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); Treatment for the prevention of respiratory syncytial virus disease; MedImmune; Approved January 1996
• Videx (didanosine); Treatment of HIV infection; Bristol-Myers Squibb; Approved June 1996
• Viramune (nevirapine); Treatment for HIV infection; Boehringer Ingelheim; Approved June 1996
• Vistide (cidofovir injection); Treatment for cytomegalovirus (CMV) retinitis; Gilead Sciences; Approved June 1996
• Vitrasert Implant; Drug delivery system for the treatment of cytomegalovirus; Chiron Vision; Approved March 1996
• Zithromax (azithromycin); Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection; Pfizer; Approved June 1996

Drugs Approved in 1995

• Cedax (ceftibuten); Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis; Schering-Plough; Approved December 1995
• Clarithromycin (Biaxin); Treatment for the prevention of disseminated Mycobacterium avium complex (MAC); Abbott Laboratories; Approved December 1995
• Epivir (lamivudine); Treatment used in combination with AZT for AIDS/HIV infection; GlaxoWellcome; Approved on November 17, 1995
• Intron A (Interferon alfa-2b, recombinant); An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma; Schering-Plough; Approved December 1995
• Invirase (saquinavir); Treatment for HIV/AIDS; Roche; Approved on December 7, 1995
• Valtrex (valacyclovir HCl); Treatment for recurrent genital herpes; GlaxoWellcome; Approved December 1995
• Western blot confirmatory device; Confirmatory test for HIV; Epitope; Approved in December 1995
• Zerit (stavudine); Treatment for HIV-infected adults who are intolerant of approved therapies; Bristol-Myers Squibb; Approved December 22, 1995
• Zyrtec (cetirizine HCl); Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives; Pfizer; Approved December 1995