Asthma

• 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 · 2022-03-01
  FDA Approved: PROVOCHOLINE — Supplemental Application (Methapharm Inc.)

  FDA approved a supplemental application for Provocholine (methacholine chloride inhalation solution) submitted by Methapharm Inc.

• 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…

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• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Montelukast (generic, Sandoz Inc), updating the product's approval status under the ANDA. Montel…

• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast sodium from Rising Pharma Holdings, Inc., enabling changes to its labeling or indica…

• FDA approval · 2022-01-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., updating the labeling under an existing ap…

• 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 · 2021-12-17
  FDA Approved: TEZSPIRE — Original Application (Amgen Inc)

  The FDA approved Tezspire (tezepelumab-ekko) from Amgen under an original Biologics License Application. It is indicated for severe, uncontr…

• 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 · 2021-11-16
  FDA Approved: BUDESONIDE INHALATION SUSPENSION — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Budesonide Inhalation Suspension from Cipla USA Inc., confirming regulatory approval of this gen…

• 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 · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA has approved a supplemental application for montelukast sodium submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Torrent Pharmaceuticals Limited's Montelukast Sodium under ANDA 201515, clearing regulatory appr…

• FDA approval · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an approved ANDA. This action …

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

  FDA approved a supplemental application for Fluticasone Propionate HFA from Prasco Laboratories.

• 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 · 2021-08-13
  FDA Approved: ARIDOL BRONCHIAL CHALLENGE TEST KIT — Supplemental Application (Methapharm, Inc.)

  FDA approved a supplemental application for the ARIDOL Bronchial Challenge Test Kit (mannitol) from Methapharm, Inc.

• FDA approval · 2021-07-30
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Aurobindo Pharma Limited to market Montelukast sodium as a generic product.

• 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 · 2021-06-03
  FDA Approved: THEOPHYLLINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Theophylline as a new original ANDA, enabling a generic Theophylline product. Theophylline is a bronchodilator used …