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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 Pulmonary/Respiratory Diseases

Drugs Approved in 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Drugs Approved in 2013

Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October 2013

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved October 2013

Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013

Drugs Approved in 2012

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 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

Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis, Approved December 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 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

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

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Drugs Approved in 2010

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

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010

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

Drugs Approved in 2009

Adcirca (tadalafil); Eli Lilly; For the treatment of pulmonary arterial hypertension, Approved May 2009

Tyvaso (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension, Approved July 2009

Drugs Approved in 2008

Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents, Approved January 2008

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Drugs Approved in 2007

Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved June 2007

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

Drugs Approved in 2006

Brovana (arformoterol tartrate); Sepracor; For the treatment of Chronic Obstructive Pulmonary Disease, Approved in October 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

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

Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004

Drugs Approved in 2003

Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003

Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003

Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003

Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003

Drugs Approved in 2002

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

Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002

Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002

Xopenex; Sepracor; Inhaled solution for treatment of reversible obstructive airway disease, Approved February 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

DuoNeb (albuterol sulfate and ipratropium bromide); Dey Laboratories; For the treatment of bronchospasm associated with COPD, Approved March 2001

Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

NasalCrom Nasal Spray; Pharmacia & Upjohn; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001

Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001

Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001

Drugs Approved in 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

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

Drugs Approved in 1999

Accolate; AstraZeneca; zafirlukast, 10 mg and 20 mg tablets., Approved September 1999

Cafcit Injection; Roxane Laboratories; For the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age., Approved September 1999

Proventil HFA Inhalation Aerosol; 3M Pharmaceuticals; Treatment or prevention of bronchospasm, Approved June 1999

Rhinocort Aqua Nasal Spray; AstraZeneca; A nasal spray containing budesonide, Approved October 1999

Tequin; Bristol-Myers Squibb; Tequin (Injectable and Tablet), December, 1999

Tikosyn Capsules; Pfizer; Capsules of dofetilide, Approved October 1999

Drugs Approved in 1998

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

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

Curosurf; Dey Laboratories; Treatment for respiratory distress syndrome in premature infants., Approved October 1998

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

Infasurf; ONY; For the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants, Approved July 1998.

Priftin; Hoechst Marion Roussel; Treatment for pulmonary tuberculosis, Approved June 1998

Pulmozyme (dornase alfa); Genentech; Treatment for cystic fibrosis, Approved March 1998

Sclerosol Intrapleural Aerosol; Bryan Corporation; Treatment for malignant pleural effusions, Approved January 1998

Singulair; Merck; Treatment for asthma, Approved February 1998

Synagis; MedImmune; Treatment for the prevention of serious lower respiratory tract disease in infants, Approved June 1998

Drugs Approved in 1997

Ceftin (cefuroxime axetil); GlaxoSmithKline; Treatment of secondary bacterial infections of acute bronchitis, Approved September 1997

Cipro (ciprofloxacin HCl); Bayer; Treatment for acute sinusitis, Approved June 1997

Claritin RediTabs (10 mg loratadine rapidly-disintegrating tablet); Schering-Plough; Treatment for seasonal allergy symptoms, Approved January 1997

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

Flovent Rotadisk; GlaxoSmithKline; Treatment of asthma in patients four and older, Approved November 1997

Metaprotereol Sulfate Inhalation Solution, 5%; Morton Grove Pharmaceuticals; Generic equivalent of Alupentr Inhalation Solution, 5%, Approved March 1997

Omnicef; Warner-Lambert; Treatment against various bacterias, Approved December 1997

Raxar (grepafloxacin); GlaxoSmithKline; Treatment for chronic bronchitis, Approved November 1997

Serevent; GlaxoSmithKline; Treatment of asthma, Approved September 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for mild-to-moderate bronchial asthma, Approved April 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for asthma, Approved April 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for mild to moderate asthma, Approved November 1997

Tobi; PathoGenesis; Treatment for cystic fibrosis, Approved December 1997

Vanceril 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol; Schering-Plough; Treatment for asthma, Approved January 1997

Zagam (sparfloxacin) tablets; Rhone Poulenc Rorer; Treatment for community-acquired pneumonia (CAP) and chronic bronchitis, Approved January 1997

Zyflo (Zileuton); Abbott Laboratories; Treatment for asthma in patients 12 years and older, Approved January 1997

Drugs Approved in 1996

Accolate; AstraZeneca; Treatment for asthma, Approved October 1996

Allegra (fexofenadine hydrochloride); Hoechst Marion Roussel; Treatment for seasonal allergy symptoms, Approved July 1996

Astelin nasal spray; Wallace Laboratories; Treatment for seasonal allergic rhinitis, Approved November 1996

Atrovent (ipratropium bromide); Boehringer Ingelheim; Treatment for runny nose due to allergies and the common cold, Approved January 1996

Augmentin (amoxicillin/clavulanate); SmithKline Beecham; Treatment for infections involving drug-resistant bacteria, Approved February 1996

Azmacort (triamcinolone acetonide) Inhalation Aerosol; Rhone Poulenc Rorer; Treatment for asthma, Approved November 1996

Breathe Right; CNS; Treatment for breathing difficulties due to deviated nasal septum, Approved June 1996

Claritin Syrup (loratadine); Schering-Plough; Treatment for children with seasonal allergies, Approved October 1996

Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg pseudoephedrine sulfate); Schering-Plough; Treatment for nasal congestion, Approved August 1996

Covera-HS (verapamil); GD Searle, Alza; Treatment for hypertension and angina, Approved January 1996

Nasacort AQ (triamcinolone acetonide) Nasal Spray; Rhone Poulenc Rorer; Treatment for allergic rhinitis, Approved May 1996

OcuHist; Pfizer; Over-the-counter antihistamine eye drop, Approved January 1996

Pulmozyme (dornase alfa); Genentech; Treatment for cystic fibrosis patients with advanced disease, Approved December 1996

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

Tavist (clemastine fumarate); Sandoz Pharmaceuticals; Treatment for cold symptoms, Approved November 1996

Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Connaught Laboratories; Treatment for whooping cough, Approved August 1996

Vancenase AQ 84 mcg Double Strength; Schering-Plough; Treatment for allergic and non-allergic rhinitis, Approved June 1996

Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996

Zosyn (sterile piperacillin sodium/tazobactam sodium); Wyeth; Treatment for hospital-acquired pneumonia, Approved May 1996

Drugs Approved in 1995

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

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