Clinical Trial Resource Center


Clinical Trial Resource Center

FDA Approved Drugs for Pulmonary/Respiratory Diseases

Drugs Approved in 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Stiolto Respimat (tiotropium bromide and olodaterol) ; Boehringer Ingelheim; For the maintenance of chronic obstructive pulmonary disease, Approved May 2015

Drugs Approved in 2014

Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma, Approved August 2014

Esbriet (pirfenidone); InterMune; For the treatment of idiopathic pulmonary fibrosis , Approved October 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

Ofev (nintedanib); Boehringer Ingelheim; For the treatment of idiopathic pulmonary fibrosis , Approved October 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

Striverdi Respimat (olodaterol); Boehringer Ingelheim; For the treatment of chronic obstructive pulmonary disease , Approved July 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