Asthma

• FDA approval · 2018-05-21
  FDA Approved: ALBUTEROL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original application for albuterol from Amneal Pharmaceuticals NY LLC, enabling a generic albuterol inhalation product …

• FDA approval · 2018-05-18
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

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

• FDA approval · 2018-05-18
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for montelukast submitted by BluePoint Laboratories under ANDA 203366. The decision denotes appr…

• FDA approval · 2018-05-17
  FDA Approved: FLUTICASONE FUROATE ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Furoate Ellipta filed by Prasco Laboratories.

• FDA approval · 2018-05-14
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for montelukast sodium from Unichem Pharmaceuticals (USA), Inc., indicating approval of an additiona…

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• FDA approval · 2018-03-26
  FDA Approved: ASMANEX HFA — Supplemental Application (Organon LLC)

  FDA approved a supplemental NDA for ASMANEX HFA (mometasone furoate) from Organon LLC, authorizing changes via a supplemental application.

• FDA approval · 2018-03-23
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

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

• CLINICAL_TRIALS approval · 2018-03-07
  Clinical Trial Update: Dupilumab Compassionate Use Study

  Dupilumab has received marketing approval for use in asthma, moving from a compassionate-use study to commercially available treatment.

• FDA approval · 2017-12-20
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) from GlaxoSmithKline LLC, resul…

• FDA approval · 2017-12-20
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA, a fixed-dose inhaled corticosteroid/long-acting beta-agonist from Organon LLC.

• FDA approval · 2017-12-20
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the Fluticasone Propionate and Salmeterol combination by Teva, resulting in updated labeling…

• FDA approval · 2017-12-20
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for the fixed-dose inhaled combination budesonide and formoterol fumarate dihydrate from AstraZeneca…

• FDA approval · 2017-12-20
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA (fluticasone furoate and vilanterol) from GlaxoSmithKline LLC.

• FDA approval · 2017-11-16
  FDA Approved: BUDESONIDE INHALATION SUSPENSION — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for Budesonide Inhalation Suspension, a generic inhaled corticosteroid, for maintenance t…

• FDA approval · 2017-10-17
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Budesonide submitted by Padagis US LLC, expanding regulatory authorization for the product. The …

• FDA approval · 2017-10-17
  FDA Approved: ALBUTEROL SULFATE — Original Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  FDA approved the original application for albuterol sulfate, a generic inhaled bronchodilator, manufactured by Luoxin Aurovitas Pharma (Chen…

• FDA approval · 2017-10-16
  FDA Approved: CROMOLYN SODIUM INHALATION SOLUTION — Original Application (Ritedose Pharmaceuticals, LLC)

  The FDA approved an original ANDA for cromolyn sodium inhalation solution from Ritedose Pharmaceuticals, enabling a generic version of the p…

• FDA approval · 2017-09-25
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Levalbuterol by Mylan Pharmaceuticals Inc. under the ANDA process.

• FDA approval · 2017-09-22
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a Supplemental Application for Albuterol Sulfate from Sandoz Inc, indicating a regulatory update to the product's approval. The…

• FDA approval · 2017-09-11
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for the budesonide and formoterol fumarate dihydrate inhalation product from AstraZeneca (Symbic…

• FDA approval · 2017-08-03
  FDA Approved: QVAR REDIHALER — Original Application (Teva Respiratory, LLC)

  FDA approved the original application for QVAR REDIHALER (beclomethasone dipropionate HFA) by Teva Respiratory, LLC. It is approved for the …

• FDA approval · 2017-07-31
  FDA Approved: BUDESONIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's original application for budesonide (generic). Budesonide is a corticosteroid used to …

• FDA approval · 2017-07-21
  FDA Approved: ALBUTEROL SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's albuterol sulfate generic under an Original Application; albuterol sulfate is a bronchodilator used to tre…

• FDA approval · 2017-07-19
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2017-06-27
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Dulera, a combination inhaled corticosteroid and long-acting beta-agonist, submitted by Organon …