Chronic Obstructive Pulmonary Disease

• FDA approval · 2018-12-21
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT Diskus (salmeterol xinafoate) from GlaxoSmithKline.

• FDA approval · 2018-11-23
  FDA Approved: ROFLUMILAST — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved the original application for a generic roflumilast from Camber Pharmaceuticals, Inc.

• FDA approval · 2018-11-09
  FDA Approved: YUPELRI — Original Application (Viatris Specialty LLC)

  FDA approved YUPELRI (revefenacin) from Viatris Specialty LLC as an original NDA approval for chronic obstructive pulmonary disease.

• FDA approval · 2018-11-09
  FDA Approved: TUDORZA PRESSAIR — Supplemental Application (Covis Pharma US, Inc)

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

• FDA approval · 2018-11-05
  FDA Approved: LEVALBUTEROL INHALATION SOLUTION — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's levalbuterol inhalation solution as an original generic application. It is indicated for relief of broncho…

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• FDA approval · 2018-10-05
  FDA Approved: STIOLTO RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for STIOLTO RESPIMAT (tiotropium bromide and olodaterol) submitted by Boehringer Ingelheim Pharm…

• FDA approval · 2018-10-03
  FDA Approved: ROFLUMILAST — Original Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista's original application for roflumilast, a PDE-4 inhibitor, to reduce the risk of COPD exacerbations in adults …

• FDA approval · 2018-07-03
  FDA Approved: BUDESONIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Budesonide from Actavis Pharma, Inc. (ANDA205457).

• FDA approval · 2018-06-29
  FDA Approved: ALBUTEROL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for albuterol filed by Rising Pharma Holdings, Inc. under ANDA207046.

• 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 · 2018-04-24
  FDA Approved: TRELEGY ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Trelegy Ellipta by GlaxoSmithKline, updating the product labeling.

• FDA approval · 2018-04-02
  FDA Approved: STRIVERDI RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for STRIVERDI RESPIMAT (olodaterol) from Boehringer Ingelheim Pharmaceuticals, Inc.

• 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.

• 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 · 2017-10-20
  FDA Approved: INCRUSE ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for INCRUSE ELLIPTA (umeclidinium) submitted by GlaxoSmithKline LLC.

• FDA approval · 2017-10-17
  FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Umeclidinium and Vilanterol Ellipta (umeclidinium bromide and vilanterol trifenate) submitted by…

• 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 · 2017-09-25
  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 · 2017-09-18
  FDA Approved: TRELEGY ELLIPTA — Original Application (GlaxoSmithKline LLC)

  The FDA approved TRELEGY ELLIPTA for the treatment of chronic obstructive pulmonary disease in adults, marking approval of a fixed-dose trip…