Chronic Obstructive Pulmonary Disease

• FDA approval · 2022-08-16
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's generic ipratropium bromide as an Original Application (ANDA). It is indicated for COPD-related…

• FDA approval · 2022-08-16
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for ipratropium bromide as a generic inhalation product from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2022-05-26
  FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved the original application for ARFORMOTEROL TARTRATE (arformoterol tartrate) by Sun Pharmaceutical Industries, Inc., a generi…

• FDA approval · 2022-05-25
  FDA Approved: YUPELRI — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for YUPELRI (revefenacin) from Viatris Specialty LLC.

• FDA approval · 2022-05-11
  FDA Approved: TRELEGY ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for TRELEGY ELLIPTA submitted by GlaxoSmithKline LLC.

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• FDA approval · 2022-05-10
  FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original generic application for arformoterol tartrate, a bronchodilator used to treat chronic obstruc…

• FDA approval · 2022-05-10
  FDA Approved: ROFLUMILAST — Original Application (Solco Healthcare US, LLC.)

  FDA approved the original ANDA for roflumilast by Solco Healthcare US, LLC, authorizing a generic version of the COPD medication.

• FDA approval · 2022-03-31
  FDA Approved: WIXELA INHUB — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's supplemental application for WIXELA INHUB, a generic inhaled corticosteroid/long-acting beta-agonist combination (fluti…

• FDA approval · 2022-03-15
  FDA Approved: BREYNA — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Breyna, a generic budesonide/formoterol fumarate inhalation product from Mylan, as an original application.

• FDA approval · 2022-03-02
  FDA Approved: ARFORMOTEROL TARTRATE INHALATION SOLUTION — Original Application (Ritedose Pharmaceuticals, LLC)

  The FDA approved an original application for ARFORMOTEROL TARTRATE INHALATION SOLUTION (arformoterol tartrate inhalation solution) by Ritedo…

• FDA approval · 2022-02-10
  FDA Approved: ROFLUMILAST — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original ANDA for roflumilast by Zydus Pharmaceuticals USA Inc., enabling a generic version of this COPD therapy. This mark…

• FDA approval · 2022-02-07
  FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for arformoterol tartrate, a generic long-acting beta-agonist bronchodilator for chronic o…

• FDA approval · 2022-01-27
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application to market ProAir DigiHaler, a digital inhaler version of albuterol sulfate.

• FDA approval · 2022-01-27
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluticasone Propionate and Salmeterol submitted by Teva Pharmaceuticals USA, Inc. The approval u…

• FDA approval · 2021-12-28
  FDA Approved: ALBUTEROL SULFATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for albuterol sulfate by Mylan Pharmaceuticals Inc., making this generic bronchodilator available. It …

• FDA approval · 2021-12-13
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic version of fluticasone propionate and salmeterol inhalation for the maintenance treatment of asthma and chronic …

• FDA approval · 2021-11-22
  FDA Approved: FORMOTEROL FUMARATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved an original application for a generic formoterol fumarate inhalation product by Alembic Pharmaceuticals Inc. The approval makes…

• FDA approval · 2021-11-09
  FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original-application generic ARFORMOTEROL TARTRATE (arformoterol tartrate) for inhalation under an original ANDA.

• FDA approval · 2021-11-04
  FDA Approved: YUPELRI — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for YUPELRI (revefenacin) submitted by Viatris Specialty LLC.

• FDA approval · 2021-10-28
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (American Health Packaging)

  FDA approved a supplemental application for albuterol sulfate, a generic inhalation drug, submitted by American Health Packaging.

• FDA approval · 2021-09-20
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic inhalation product containing fluticasone propionate and salmeterol from Hikma Pha…

• FDA approval · 2021-08-18
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA, a combination inhaled corticosteroid and long-acting beta-agonist from GlaxoSmit…

• FDA approval · 2021-08-18
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2021-07-09
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental NDA for Fluticasone Propionate and Salmeterol (Teva) to update the product labeling.

• FDA approval · 2021-06-22
  FDA Approved: ARFORMOTEROL TARTRATE INHALATION — Original Application (Slate Run Pharmaceuticals)

  FDA approved Slate Run Pharmaceuticals' ARFORMOTEROL TARTRATE INHALATION for the maintenance treatment of chronic obstructive pulmonary dise…