Approved Drugs for Pulmonary/Respiratory Diseases

Drugs Approved in 2008

• Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
• Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008

Drugs Approved in 2007

• Letairis (ambrisentan); For the treatment of pulmonary arterial hypertension; Gilead; Approved June 2007
• Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Drugs Approved in 2006

• Brovana (arformoterol tartrate); For the treatment of Chronic Obstructive Pulmonary Disease; Sepracor; Approved in October 2006

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

Drugs Approved in 2003

• Aldurazyme (laronidase); For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65; Genzyme; Approved May 2003
• Iressa (gefitinib); For the second-line treatment of non-small-cell lung cancer; AstraZeneca; Approved May 2003
• Zemaira (alpha1-proteinase inhibitor); For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema; Aventis Behring; Approved July 2003

Drugs Approved in 2002

• Clarinex; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria; Schering-Plough; Approved February 2002
• Qvar (beclomethasone dipropionate); For the treatment of asthma; Ivax; Approved May 2002
• Remodulin (treprostinil); For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms; United Therapeutics; Approved May 2002
• Xopenex; Inhaled solution for treatment of reversible obstructive airway disease; Sepracor; Approved February 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
• DuoNeb (albuterol sulfate and ipratropium bromide); For the treatment of bronchospasm associated with COPD; Dey Laboratories; Approved March 2001
• Foradil Aerolizer (formoterol fumarate inhalation powder); Bronchodilator for COPD, asthma and bronchospasm; Novartis; Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)
• Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001
• NasalCrom Nasal Spray; Over-the-counter nasal spray for treatment of all nasal allergy symptoms; Pharmacia; Approved April 2001
• Tavist Allergy/Sinus/Headache; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold; Novartis; Approved March 2001
• Tracleer (bosentan); For the treatment of pulmonary arterial hypertension; Actelion; Approved November 2001
• Ventolin HFA (albuterol sulfate inhalation aerosol); For the treatment or prevention of bronchospasm; GlaxoSmithKline; Approved April 2001

Drugs Approved in 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
• 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

Drugs Approved in 1999

• Accolate; zafirlukast, 10 mg and 20 mg tablets.; AstraZeneca; Approved September 1999
• Cafcit Injection; For the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.; Roxane Laboratories; Approved September 1999
• Proventil HFA Inhalation Aerosol; Treatment or prevention of bronchospasm; 3M Pharmaceuticals; Approved June 1999
• Rhinocort Aqua Nasal Spray; A nasal spray containing budesonide; AstraZeneca; Approved October 1999
• Tequin; Tequin (Injectable and Tablet); Bristol-Myers Squibb; December, 1999
• Tikosyn Capsules; Capsules of dofetilide; Pfizer; Approved October 1999

Drugs Approved in 1998

• Allegra-D; Treatment for nasal congestion due to seasonal allergy; Hoechst Marion Roussel; Approved March 1998
• Clemastine fumarate syrup; Generic equivalent of Tavist Syrup; Morton Grove Pharmaceuticals; Approved March 1998
• Curosurf; Treatment for respiratory distress syndrome in premature infants.; Dey Laboratories; Approved October 1998
• Dynabac; Treatment for acute bacterial exacerbations (chronic bronchitis and skin infections); Sanofi Pharmaceuticals; Approved March 1998
• Infasurf; For the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants; ONY; Approved July 1998.
• Priftin; Treatment for pulmonary tuberculosis; Hoechst Marion Roussel; Approved June 1998
• Pulmozyme Inhalation Solution; Treatment for cystic fibrosis; Genentech; Approved March 1998
• Sclerosol Intrapleural Aerosol; Treatment for malignant pleural effusions; Bryan Corporation; Approved January 1998
• Singulair; Treatment for asthma; Merck; Approved February 1998
• Synagis; Treatment for the prevention of serious lower respiratory tract disease in infants; MedImmune; Approved June 1998

Drugs Approved in 1997

• Ceftin (cefuroxime axetil); Treatment of secondary bacterial infections of acute bronchitis; GlaxoWellcome; Approved September 1997
• Cipro; Treatment for acute sinusitis; Bayer; Approved June 1997
• Claritin RediTabs (10 mg loratadine rapidly-disintegrating tablet); Treatment for seasonal allergy symptoms; Schering-Plough; Approved January 1997
• Flonase Nasal Spray; Treatment for seasonal and perennial allergic rhinitis; GlaxoWellcome; Approved November 1997
• Flovent Rotadisk; Treatment of asthma in patients four and older; GlaxoWellcome; Approved November 1997
• Metaprotereol Sulfate Inhalation Solution, 5%; Generic equivalent of Alupentr Inhalation Solution, 5%; Morton Grove Pharmaceuticals; Approved March 1997
• Nasacort AQ (triamcinolone acetonide) Nasal Spray; Treatment of nasal symptoms of seasonal allergic rhinitis in children Aged 6-11; Phone-Poulenc Rorer; Approved October 1997
• Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997
• Raxar (grepafloxacin); Treatment for chronic bronchitis; GlaxoWellcome; Approved November 1997
• Serevent; Treatment of asthma; GlaxoWellcome; Approved September 1997
• Tilade; Treatment for asthma; Rhone Poulenc Rorer; Approved April 1997
• Tilade (nedocromil sodium) inhaler; Treatment for mild-to-moderate bronchial asthma; Rhone Poulenc Rorer; Approved April 1997
• Tilade Nebulizer Solution; Treatment for mild to moderate asthma; Rhone Poulenc Rorer; Approved November 1997
• Tobi; Treatment for cystic fibrosis; PathoGenesis; Approved December 1997
• Vanceril 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol; Treatment for asthma; Schering-Plough; Approved January 1997
• Zagam (sparfloxacin) tablets; Treatment for community-acquired pneumonia (CAP) and chronic bronchitis; Rhone Poulenc Rorer; Approved January 1997
• Zyflo (Zileuton); Treatment for asthma in patients 12 years and older; Abbott Laboratories; Approved January 1997

Drugs Approved in 1996

• Accolate; Treatment for asthma; Zeneca Pharmaceuticals; Approved October 1996
• Allegra (fexofenadine hydrochloride); Treatment for seasonal allergy symptoms; Hoechst Marion Roussel; Approved July 1996
• Astelin nasal spray; Treatment for seasonal allergic rhinitis; Wallace Laboratories; Approved November 1996
• Atrovent (ipratropium bromide); Treatment for runny nose due to allergies and the common cold; Boehringer Ingelheim; Approved January 1996
• Augmentin (amoxicillin/clavulanate); Treatment for infections involving drug-resistant bacteria; SmithKline Beecham; Approved February 1996
• Azmacort (triamcinolone acetonide) Inhalation Aerosol; Treatment for asthma; Rhone Poulenc Rorer; Approved November 1996
• Breathe Right; Treatment for breathing difficulties due to deviated nasal septum; CNS; Approved June 1996
• Claritin Syrup (loratadine); Treatment for children with seasonal allergies; Schering-Plough; Approved October 1996
• Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg pseudoephedrine sulfate); Treatment for nasal congestion; Schering-Plough; Approved August 1996
• Covera-HS (verapamil); Treatment for hypertension and angina; G.D. Searle, Alza; Approved January 1996
• Nasacort AQ (triamcinolone acetonide) Nasal Spray; Treatment for allergic rhinitis; Rhone Poulenc Rorer; Approved May 1996
• OcuHist; Over-the-counter antihistamine eye drop; Pfizer; Approved January 1996
• Pulmozyme (dornase alfa); Treatment for cystic fibrosis patients with advanced disease; Genentech; Approved December 1996
• RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); Treatment for the prevention of respiratory syncytial virus disease; MedImmune; Approved January 1996
• Tavist-D; Treatment for cold symptoms; Sandoz Pharmaceuticals; Approved November 1996
• Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Treatment for whooping cough; Connaught Laboratories; Approved August 1996
• Vancenase AQ 84 mcg Double Strength; Treatment for allergic and non-allergic rhinitis; Schering-Plough; Approved June 1996
• Visipaque (iodixanol); Diagnostic contrast agent; Nycomed; Approved April 1996
• Zosyn (sterile piperacillin sodium/tazobactam sodium); Treatment for hospital-acquired pneumonia; Wyeth-Ayerst Laboratories; Approved May 1996

Drugs Approved in 1995

• Cedax (ceftibuten); Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis; Schering-Plough; Approved December 1995
• Zyrtec (cetirizine HCl); Treatment for year-round allergies, seasonal allergic rhinitis, and chronic itching and hives; Pfizer; Approved December 1995