FDA Approved Drugs for Immunology

Drugs Approved in 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Drugs Approved in 2012

Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012

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

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

Drugs Approved in 2011

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011

Firazyr (icatibant); Shire Pharmaceuticals; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott Laboratories; For the treatment of postherpetic neuralgia, Approved February 2011

Incivek (telaprevir); Vertex Pharmaceuticals; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

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

Drugs Approved in 2010

Cayston (aztreonam for inhalation solution); Gilead; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010

Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive meningococcal disease, Approved February 2010

Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010

Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine); Wyeth; For the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae, Approved February 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010

Drugs Approved in 2009

Bepreve (bepotastine besilate ophthalmic solution); Ista Pharmaceuticals; For the treatment of itching associated with allergic conjunctivitis, Approved September 2009

Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009

Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial conjunctivitis, Approved June 2009

Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009

Coartem (artemether/lumefantrine); Novartis; For the treatment of malaria infections due to Plasmodium falciparum, Approved April 2009

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009

Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009

Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed); Intercell AG; For the prevention of disease caused by Japanese encephalitis virus, Approved March 2009

Kalbitor (ecallantide); Dyax; For the treatment of hereditary angioedema, Approved November 2009

Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009

Vibativ (telavancin); Theravance; For the treatment of complicated skin and skin structure infections, Approved September 2009

Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic keratitis, Approved September 2009

Drugs Approved in 2008

Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc.; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008

Intelence (etravirine); Tibotec; For the treatment of HIV-1, Approved January 2008

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 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

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

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Drugs Approved in 2007

Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007

AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved April 2007

Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007

Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007

Isentress (raltegravir); Merck; For the treatment of HIV-1, Approved October 2007

Selzentry (maraviroc); Pfizer; For the treatment of CCR5-tropic HIV-1, Approved August 2007

Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007

Drugs Approved in 2006

Eraxis (anidulafungin); Pfizer; For the treatment of Candida fungal infections, Approved February 2006

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June 2006

Noxafil (posaconazole); Schering-Plough; For the treatment of fungal infections, Approved in September 2006

Prezista (darunavir); Tibotec; For the treatment of treatment-resistant HIV infections, Approved June 2006

Rotateq (rotavirus vaccine, live oral pentavalent); Merck; For the prevention of gastroenteritis associated with rotavirus infections in infants, Approved February 2006

Tyzeka (telbivudine); Idenix Pharma; For the treatment of hepatitis B virus, Approved October 2006

Veregen (kunecatechins); Medigene; For the treatment of external genital and perianal warts, Approved October 2006

Drugs Approved in 2005

Aptivus (tipranavir); Boehringer Ingelheim; For the adjunctive treatment of HIV-1 infections, Approved June, 2005

Baraclude (entecavir); Bristol-Myers Squibb; For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 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

Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia., Approved April 2004

Tindamax, tinidazole; Presutti Laboratories; For the treatment of microbial infections, including trichomoniasis, giardiasis, and amebiasis, Approved May, 2004

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli, Approved May 2004

Drugs Approved in 2003

Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003

FluMist ( Influenza Virus Vaccine); MedImmune; For the prevention of disease caused by influenza A and B viruses, Approved June 2003

Fuzeon (enfuvirtide); Trimeris, Roche; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003

Lexiva (fosamprenavir calcium); GlaxoSmithKline; For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003

Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003

Drugs Approved in 2002

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

Clarinex; Schering-Plough; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002

Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002

Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002

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

Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002

Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002

Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear production., December 2002

Sustiva; Bristol-Myers Squibb; Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002

Vfend (voriconazole); Pfizer; For the treatment of fungal infections, Approved May 2002

Drugs Approved in 2001

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001

Xigris (drotrecogin alfa [activated]); Eli Lilly; For the treatment of severe sepsis, Approved November 2001

Drugs Approved in 2000

ABREVA (docosanol); AVANIR PHARMACEUTICALS; Cold sore/fever blister, Approved July 2000

Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000

Evoxac; SnowBrand Pharmaceuticals; For the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome, Approved January 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Lotrisone (clotrimazole/betamethasone diproprionate) lotion; Schering-Plough; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis, Approved December 2000

Malarone (atovaquone; proguanil hydrochloride) Tablet; GlaxoSmithKline; For the treatment and prevention of Plasmodium falciparum malaria, Approved July 2000

Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August 2000

Rid Mousse; Soltec Research; For the treatment of head, pubic (crab), and body lice, Approved March 2000

Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000

Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of vaginal yeast infections, Approved April 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000

Drugs Approved in 1999

Agenerase (amprenavir); GlaxoSmithKline; For the treatment of HIV-1 infection., Approved April 1999

Cleocin (clindamycin phosphate); Pharmacia & Upjohn; Treatment for bacterial vaginosis, Approved August 1999

Famvir (famciclovir); SmithKline Beecham; Treatment for Herpes Simplex Infections in HIV-infected patients, Approved January 1999

Norvir (ritonavir); Abbott Laboratories; Treatment for HIV infection, Approved June 1999

Panretin Gel; Ligand Pharmaceuticals; Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma., Approved June 1999

Rapamune (sirolimus) oral solution; Wyeth; Oral solution of sirolimus, Approved September 1999

Relenza; GlaxoSmithKline; Treatment for uncomplicated acute illness due to influenza virus, Approved July 1999

Synercid I.V.; Rhone Poulenc Rorer; quinupristin and dalfopristin for injection, Approved September 1999

Tamiflu capsule; Roche; Oseltamivir phosphate capsule, October 27, 1999

Vistide (cidofovir); Gilead; For the treatment of cytomegalovirus (CMV) retinitis, Approved March 1999

Drugs Approved in 1998

Allegra-D; Hoechst Marion Roussel; Treatment for nasal congestion due to seasonal allergy, Approved March 1998

CellCept; Roche; Treatment for the prevention of organ rejection inpatients undergoing heart transplants, Approved February 1998

Clemastine fumarate syrup; Morton Grove Pharmaceuticals; Generic equivalent of Tavist Syrup, Approved March 1998

Cleocin (clindamycin phosphate); Pharmacia & Upjohn; Treatment for bacterial vaginosis, Approved March 1998

Dynabac; Sanofi-aventis; Treatment for acute bacterial exacerbations (chronic bronchitis and skin infections), Approved March 1998

REBETRON (TM) Combination Therapy; Schering-Plough; Treatment for Chronic Hepatitis C, Approved June 1998

Simulect; Novartis; Treatment for acute organ transplant rejection, Approved May 1998

Timentin; SmithKline Beecham; Treatment for wide range of infections in children, Approved January 1998

Viroptic; King Pharmaceuticals; Treatment for inflammation of the cornea in children due to herpes simplex virus, Approved February 1998

Drugs Approved in 1997

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); SmithKline Beecham; Treatment for diphtheria, tetanus and pertussis (whooping cough) in infants and children, January 1997

Acyclovir Capsules; Teva Pharmaceutical; Generic equivalent of Zovirax, Approved April 1997

Aldara (imiquimod); 3M Pharmaceuticals; Treatment for external genital and perianal warts, Approved March 1997

Aphthasol; Block Drug Company; Treatment for canker sores, Approved December 1997

Combivir; GlaxoSmithKline; Treatment for AIDS and HIV Infection, Approved September 1997

Condylox Gel 0.5% (pokofilox); Oclassen Pharmaceuticals; Treatment for external genital and perianal warts, Approved March 1997

Famvir (famciclovir); SmithKline Beecham; Treatment for genital herpes, Approved September 17, 1997

Flagyl ER; Searle; Treatment for bacterial vaginosis, Approved December 1997

Flonase Nasal Spray; GlaxoSmithKline; Treatment for seasonal and perennial allergic rhinitis, Approved November 1997

Fortovase; Roche; Treatment for HIV infection, Approved November 1997

INFERGEN (interferon alfacon-1); Amgen; Treatment for chronic hepatitis C virus, Approved October 1997

Intron A (interferon alfa-2b, recombinant); Schering-Plough; Treatment for hepatitis C, Approved March 1997

Norvir (ritonavir); Abbott Laboratories; Treatment for HIV infection, Approved March 1996/March 1997

Rescriptor Tablets (delavirdine mesylate tablets); Pharmacia & Upjohn; Treatment for HIV-1 infection, Approved April 1997

SPORANOX (itraconazole); Janssen Pharmaceuticals; Treatment for oral thrush, Approved March 1997

Stromectol (ivermectin); Merck; Treatment for nondisseminated intestinal threadworm, Approved March 1997

Taxol; Bristol-Myers Squibb; Treatment for AIDS-related Kaposi's Sarcoma, Approved August 1997

Trovan; Pfizer; Treatment for bacterial infections, Approved December 1997

VIRACEPT (nelfinavir mesylate); Agouron Pharmaceuticals; Treatment for HIV infection in adults and children, Approved March 1997

Zerit (stavudine); Bristol-Myers Squibb; Treatment for infants and children infected with HIV, Approved January 1997

Drugs Approved in 1996

Albenza (albendazole); SmithKline Beecham; Treatment for parasitic infections caused by worms, Approved June 1996

Apthasol (Amlexanox); Access Pharmaceuticals; Treatment for canker sores, Approved May 1996

Carrington patch; Carrington Laboratories; Treatment for canker sores, Approved May 1996

Confide; Johnson & Johnson; HIV testing and counseling service, Approved May 1996

Crixivan (Indinavir sulfate); Merck; Treatment for HIV infection, Approved March 1996

Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer; Treatment for mastocytosis, Approved April 1996

Havrix; SmithKline Beecham; Treatment for hepatitis A, Approved March 1996

Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals; Treatment for nail fungal infections, Approved May 1996

Leukine (sargramostim); Immunex; Treatment for the replenishment of white blood cells, Approved November 1996

Oral Cytovene; Roche; Treatment for the prevention of cytomegalovirus (CMV), Approved December 1996

RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune; Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996

Videx (didanosine); Bristol-Myers Squibb; Treatment of HIV infection, Approved June 1996

Viramune (nevirapine); Boehringer Ingelheim; Treatment for HIV infection, Approved June 1996

Vistide (cidofovir); Gilead; Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996

Vitrasert Implant; Chiron; Drug delivery system for the treatment of cytomegalovirus, Approved March 1996

Zithromax (azithromycin); Pfizer; Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection, Approved June 1996

Drugs Approved in 1995

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Clarithromycin (Biaxin); Abbott Laboratories; Treatment for the prevention of disseminated Mycobacterium avium complex (MAC), Approved December 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Valtrex (valacyclovir HCl); GlaxoSmithKline; Treatment for recurrent genital herpes, Approved December 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Zerit (stavudine); Bristol-Myers Squibb; Treatment for HIV-infected adults who are intolerant of approved therapies, Approved December 22, 1995

Zyrtec (cetirizine HCl); Pfizer; Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives, Approved December 1995