Chronic Obstructive Pulmonary Disease

• FDA approval · 2015-03-02
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for BREO ELLIPTA (fluticasone furoate and vilanterol trifenatate) submitted by GlaxoSmithKline L…

• FDA approval · 2015-02-03
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for albuterol sulfate submitted by Sandoz Inc.

• FDA approval · 2014-12-19
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline LLC.

• FDA approval · 2014-12-10
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) from GlaxoSmithKline LLC.

• FDA approval · 2014-11-14
  FDA Approved: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate HFA submitted by Prasco Laboratories, confirming a regulatory change for …

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• FDA approval · 2014-11-13
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA, the combination inhaled therapy of fluticasone propionate and salmeterol xinafoa…

• FDA approval · 2014-11-13
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate Diskus by Prasco Laboratories.

• FDA approval · 2014-11-13
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) from GlaxoSmithKline LLC under NDA 021077.

• FDA approval · 2014-10-30
  FDA Approved: TUDORZA PRESSAIR — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Tudorza Pressair (aclidinium bromide) submitted by Covis Pharma US, Inc.

• FDA approval · 2014-10-23
  FDA Approved: TUDORZA PRESSAIR — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Tudorza Pressair (aclidinium bromide) submitted by Covis Pharma US, Inc.

• FDA approval · 2014-10-21
  FDA Approved: TERBUTALINE SULFATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for terbutaline sulfate from Fresenius Kabi USA, LLC, indicating an additional authorization related…

• FDA approval · 2014-09-24
  FDA Approved: SPIRIVA RESPIMAT — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved Spiriva Respimat (tiotropium bromide inhalation spray) from Boehringer Ingelheim as an original drug approval for chronic o…

• FDA approval · 2014-09-17
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Daliresp (roflumilast) submitted by AstraZeneca Pharmaceuticals LP. The action approves chan…

• FDA approval · 2014-08-27
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XOPENEX HFA (levalbuterol tartrate) submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2014-08-14
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Combivent Respimat (ipratropium bromide and albuterol) from Boehringer Ingelheim Pharmaceuti…

• FDA approval · 2014-07-31
  FDA Approved: STRIVERDI RESPIMAT — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved Striverdi Respimat (olodaterol inhalation spray) as an original application from Boehringer Ingelheim for the treatment of …

• FDA approval · 2014-07-17
  FDA Approved: TUDORZA PRESSAIR — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Tudorza Pressair (aclidinium bromide) submitted by Covis Pharma US, Inc.

• FDA approval · 2014-06-28
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide and formoterol fumarate dihydrate (AstraZeneca) to expand its approved indications fo…

• FDA approval · 2014-06-19
  FDA Approved: COMBIVENT RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Combivent Respimat (ipratropium bromide and albuterol) from Boehringer Ingelheim Pharmaceuti…

• FDA approval · 2014-06-17
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2014-06-17
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) submitted by GlaxoSmithKline.

• FDA approval · 2014-06-17
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2014-04-30
  FDA Approved: INCRUSE ELLIPTA — Original Application (GlaxoSmithKline LLC)

  FDA approved Incruse Ellipta (umeclidinium) through an original application for the treatment of chronic obstructive pulmonary disease. This…

• FDA approval · 2014-04-17
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) from Organon LLC, indicating a lab…

• FDA approval · 2014-04-14
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) from GlaxoSmithKline.