Asthma

• FDA label_change · 2025-05-22
  FDA Approved: EBGLYSS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for EBGLYSS (lebrikizumab-lbkz) from Eli Lilly, affecting the drug's label.

• FDA label_change · 2023-05-10
  FDA Approved: METHYLPREDNISOLONE ACETATE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for methylprednisolone acetate by Sandoz Inc.

• FDA label_change · 2021-02-22
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast sodium) filed by Organon LLC, resulting in changes to the product lab…

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

  The FDA approved a supplemental application for ASMANEX (mometasone furoate) from Organon LLC, resulting in changes to the product labeling.

• FDA label_change · 2018-03-02
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the inhaled combination product fluticasone propionate and salmeterol, resulting in changes to i…

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• FDA label_change · 2016-12-13
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) by Organon LLC, resulting in updated labeling for the product.

• FDA label_change · 2016-11-09
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ALBUTEROL SULFATE from Sandoz Inc, resulting in changes to the product labeling.

• FDA label_change · 2016-09-08
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for ProAir Digihaler (albuterol sulfate) by Teva Respiratory, LLC, typically indicating an updat…

• FDA label_change · 2016-07-06
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) to update its labeling.

• FDA label_change · 2016-02-16
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA submitted by GlaxoSmithKline LLC to update its labeling.

• FDA label_change · 2015-08-06
  FDA Approved: ASMANEX HFA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ASMANEX HFA (mometasone furoate) to update the product labeling.

• FDA label_change · 2014-11-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a labeling supplemental application for Singulair (montelukast) submitted by Organon LLC.

• FDA label_change · 2014-09-26
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, resulting in a label change/indication update for th…

• FDA label_change · 2014-05-09
  FDA Approved: ATROVENT HFA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ATROVENT HFA (ipratropium bromide) from Boehringer Ingelheim Pharmaceuticals, Inc., reflecti…

• FDA label_change · 2013-05-15
  FDA Approved: PULMICORT RESPULES — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Pulmicort RespuLes (budesonide) from AstraZeneca, resulting in labeling changes.

• FDA label_change · 2013-03-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC, resulting in a labeling change for the product.

• FDA label_change · 2012-08-09
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC, resulting in changes to the pro…

• FDA label_change · 2011-06-10
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC, likely affecting labeling and/or indications.

• FDA label_change · 2010-04-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast) from Organon LLC, indicating a labeling change associated with the p…

• FDA label_change · 2010-04-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair to update labeling; Organon LLC submitted the request.

• FDA label_change · 2009-10-05
  FDA Approved: PULMICORT RESPULES — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Pulmicort Respules (budesonide) from AstraZeneca Pharmaceuticals LP. This action updates the…

• FDA label_change · 2009-08-21
  FDA Approved: ZYFLO — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for ZYFLO (zileuton) from Chiesi USA, Inc., resulting in a labeling change.

• FDA label_change · 2009-01-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application to update the labeling for Singulair (montelukast) under Organon LLC.

• FDA label_change · 2008-05-29
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast from Strides Pharma Science Limited, indicating a labeling update to the already app…

• FDA label_change · 2007-04-13
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC. The approval updates the drug's labelin…