Asthma

• FDA approval · 2015-03-12
  FDA Approved: MONTELUKAST SODIUM — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved Montelukast Sodium from Macleods Pharmaceuticals Limited under an Original Application (ANDA 203582).

• 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: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate HFA submitted by Prasco Laboratories, leading to labeling changes und…

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• 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 · 2014-11-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon 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 …

• 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 · 2014-10-21
  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 · 2014-09-11
  FDA Approved: MONTELUKAST — Original Application (BluePoint Laboratories)

  FDA approved Montelukast from BluePoint Laboratories under an Original Application (ANDA), granting generic montelukast access for approved …

• FDA approval · 2014-09-10
  FDA Approved: MONTELUKAST — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approves the original abbreviated new drug application for Montelukast (generic) submitted by XLCare Pharmaceuticals Inc.

• 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 · 2014-06-28
  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 · 2014-06-17
  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: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate HFA from Prasco Laboratories, confirming its continued use as an inha…

• 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 · 2014-06-17
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate Diskus, with Prasco Laboratories as sponsor.

• FDA approval · 2014-04-25
  FDA Approved: ASMANEX HFA — Original Application (Organon LLC)

  FDA approved the original application for ASMANEX HFA (mometasone furoate) from Organon LLC. The inhaled corticosteroid is used for the main…

• FDA approval · 2014-04-22
  FDA Approved: ALVESCO — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for ALVESCO (ciclesonide) submitted by Covis Pharma US, Inc.

• 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.