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
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area list to assist you in your search.
FDA Approved Drugs for Pulmonary/Respiratory Diseases
Drugs Approved in 2013
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline;
For the treatment of chronic obstructive pulmonary disease, Approved May 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); G.D. 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
