Exercise-induced Bronchoconstriction
📧 Sign up to get email alerts when something new happens for Exercise-induced Bronchoconstriction.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2012-08-06FDA Approved: MONTELUKAST SODIUM — Original Application (Dr.Reddy's Laboratories Limited)
FDA approves the original ANDA for Montelukast sodium from Dr. Reddy's Laboratories Limited, establishing a generic Montelukast sodium produ…
-
FDA approval · 2012-08-03FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for a generic montelukast sodium product from Rising Pharma Holdings, Inc. under ANDA 202468.
-
FDA approval · 2012-08-03FDA Approved: MONTELUKAST SODIUM — Original Application (Lannett Company, Inc.)
FDA approves the original application for Montelukast Sodium (generic montelukast) manufactured by Lannett Company, Inc. The approval enable…
-
FDA approval · 2012-08-03FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's Montelukast Sodium as an original generic application (ANDA 201515).
-
FDA approval · 2012-08-03FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium, establishing a generic version of montelukast for the a…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2012-02-22Clinical Trial Update: Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects [Phase 2]
A Phase 2 trial evaluating the dose-response of levalbuterol versus racemic albuterol to prevent exercise-induced bronchoconstriction in ped…
-
CLINICAL_TRIALS trial_result · 2012-02-22Clinical Trial Update: Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol [Phase 3]
This is a completed Phase 3 trial comparing levalbuterol to racemic albuterol for the prevention of exercise-induced bronchoconstriction in …
-
FDA approval · 2011-12-16FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, resulting in an update to the product labeling via a sup…
-
FDA approval · 2011-12-16FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC. The approval updates the product labeli…
-
FDA approval · 2011-06-10FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved Organon LLC's supplemental application for Singulair (montelukast sodium), granting approval of the requested supplemental acti…
-
FDA label_change · 2011-06-10FDA 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 approval · 2011-04-27FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC.
-
FDA approval · 2011-04-27FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC.
-
FDA approval · 2011-04-27FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in updated labeling for the p…
-
CLINICAL_TRIALS trial_result · 2011-04-07Clinical Trial Update: The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED) [Phase 4]
Phase 4 trial evaluated Montelukast for reducing difficulty in breathing after exercise in pediatric patients with exercise-induced bronchoc…
-
FDA approval · 2010-08-10FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast) filed by Organon LLC, resulting in labeling changes to reflect the suppl…
-
CLINICAL_TRIALS trial_result · 2010-05-27Clinical Trial Update: Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316) [Phase 3]
Phase 3 trial comparing montelukast with placebo and salmeterol for exercise-induced bronchoconstriction in asthma; results completed with p…
-
FDA label_change · 2010-04-26FDA 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 · 2010-04-26FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair to update labeling; Organon LLC submitted the request.
-
CLINICAL_TRIALS trial_result · 2009-12-03Clinical Trial Update: Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) [Phase 3]
Phase 3 trial evaluating two investigational drugs to prevent exercise-induced airway constriction in people with asthma has completed, and …
-
FDA approval · 2009-09-08FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for albuterol sulfate by Sandoz Inc, updating an existing approved product.
-
FDA approval · 2009-08-19FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a Supplemental Application for Singulair (montelukast sodium) submitted by Organon LLC. This action typically results in labeli…
-
FDA approval · 2009-08-19FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.
-
CLINICAL_TRIALS trial_result · 2009-07-09Clinical Trial Update: Time-Effect of Montelukast Protection [Phase 4]
Phase 4 trial assessing the time-dependent protective effects of Montelukast in asthma and exercise-induced bronchoconstriction has complete…
-
FDA label_change · 2009-01-27FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application to update the labeling for Singulair (montelukast) under Organon LLC.