Asthma

• FDA approval · 2015-09-25
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast Sodium submitted by Macleods Pharmaceuticals Limited.

• FDA approval · 2015-09-18
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-09-15
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA (fluticasone furoate and vilanterol) from GlaxoSmithKline, resulting in label chang…

• FDA approval · 2015-09-04
  FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's Montelukast Sodium as a generic version under an Original Abbreviated New Drug Application. Montel…

• FDA approval · 2015-08-18
  FDA Approved: PULMICORT RESPULES — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Pulmicort Respules (budesonide) from AstraZeneca Pharmaceuticals LP, signaling an approved c…

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• FDA approval · 2015-08-14
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2015-08-06
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-08-03
  FDA Approved: ASMANEX HFA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ASMANEX HFA (mometasone furoate) from Organon LLC. The approval relates to a modification to…

• FDA approval · 2015-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Montelukast Sodium as an original application generic product for Ajanta Pharma USA Inc.

• FDA approval · 2015-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s montelukast sodium generic under an Original Application (ANDA 203432). The product is approved for th…

• FDA approval · 2015-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for montelukast sodium (generic montelukast), authorizing a generic product for t…

• FDA approval · 2015-07-30
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for PROAIR DIGIHALER (albuterol sulfate) submitted by Teva Respiratory, LLC.

• FDA approval · 2015-07-16
  FDA Approved: PULMICORT FLEXHALER — Supplemental Application (H2-Pharma LLC)

  The FDA has approved a supplemental application for Pulmicort Flexhaler (budesonide) submitted by H2-Pharma LLC.

• FDA approval · 2015-06-16
  FDA Approved: ASMANEX HFA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ASMANEX HFA (mometasone furoate) from Organon LLC. The action updates or expands the product…

• FDA approval · 2015-06-03
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for budesonide submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2015-05-22
  FDA Approved: MONTELUKAST SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original generic application for montelukast sodium, enabling marketing of a generic montelukast pr…

• FDA approval · 2015-05-04
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a Supplemental Application for montelukast submitted by Sandoz Inc.

• FDA approval · 2015-04-30
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Breo Ellipta (fluticasone furoate and vilanterol) from GlaxoSmithKline, updating its labeling/in…

• FDA approval · 2015-04-23
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-04-14
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide/formoterol fumarate dihydrate from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2015-04-13
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Triamcinolone Acetonide via an Original Application (ANDA) for Padagis Israel Pharmaceuticals Ltd., authorizing a generic corti…

• FDA approval · 2015-03-31
  FDA Approved: PROAIR DIGIHALER — Original Application (Teva Respiratory, LLC)

  FDA approved PROAIR DIGIHALER (albuterol sulfate) from Teva Respiratory under an Original Application, introducing a digital inhaler version…

• FDA approval · 2015-03-20
  FDA Approved: FLUTICASONE FUROATE ELLIPTA — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for Fluticasone furoate Ellipta, enabling a generic version of the inha…

• FDA approval · 2015-03-16
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s supplemental application for Montelukast Sodium.

• FDA approval · 2015-03-12
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XOPENEX HFA (levalbuterol tartrate) from Lupin Pharmaceuticals, approving changes to the product…