Chronic Obstructive Pulmonary Disease

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

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC. The approval updates or exp…

• FDA approval · 2014-04-14
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application to allow Prasco Laboratories to market Fluticasone Propionate Diskus.

• FDA approval · 2014-03-19
  FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for formoterol fumarate (Mylan Pharmaceuticals Inc.). The action updates the product labeling and ma…

• FDA approval · 2014-02-27
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Budesonide and Formoterol Fumarate Dihydrate (Symbicort) from AstraZeneca Pharmaceuticals LP…

• FDA approval · 2014-01-21
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline, expanding the labeling per the supplement…

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• FDA approval · 2014-01-08
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for ALBUTEROL SULFATE HFA from Teva Pharmaceuticals USA, Inc. This action relates to a regulator…

• FDA approval · 2014-01-03
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Ventolin HFA (albuterol sulfate) filed by GlaxoSmithKline LLC.

• FDA approval · 2013-12-18
  FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Original Application (Prasco Laboratories)

  The FDA approved Prasco Laboratories' original application for umeclidinium bromide and vilanterol Ellipta, a combined LAMA/LABA inhalation …

• FDA approval · 2013-09-10
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2013-08-23
  FDA Approved: DALIRESP — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for DalireSP (roflumilast) from AstraZeneca Pharmaceuticals LP, resulting in an updated label.

• FDA approval · 2013-08-21
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) by Organon LLC.

• FDA approval · 2013-07-30
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.

• FDA approval · 2013-06-19
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA granted supplemental approval for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) by GlaxoSmithKline LLC, updating the …

• FDA approval · 2013-06-19
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2013-06-19
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2013-06-10
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.

• FDA approval · 2013-05-10
  FDA Approved: BREO ELLIPTA — Original Application (GlaxoSmithKline LLC)

  FDA approved Breo Ellipta (fluticasone furoate and vilanterol) in its original application. It is an inhaled corticosteroid/long-acting beta…

• FDA approval · 2013-05-03
  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 · 2013-04-26
  FDA Approved: LEVALBUTEROL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's LEVALBUTEROL as a generic inhalation solution (Original Application) for preventing and treating bronchospasm in reversi…

• FDA approval · 2013-03-23
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Albuterol Sulfate HFA (Teva Pharmaceuticals USA, Inc.), indicating regulatory action to modify t…

• FDA approval · 2013-03-14
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2013-02-25
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2013-02-19
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application from Mylan Pharmaceuticals Inc. for Levalbuterol, confirming the availability of a generic bronc…

• FDA approval · 2013-01-31
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for the ipratropium bromide and albuterol sulfate inhalation product (IPRATROPIUM BRO…

• FDA approval · 2013-01-25
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.