Chronic Obstructive Pulmonary Disease
📧 Sign up to get email alerts when something new happens for Chronic Obstructive Pulmonary Disease.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2024-12-27FDA Approved: SPIRIVA RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)
FDA approved a supplemental application for Spiriva Respimat (tiotropium bromide inhalation spray) from Boehringer Ingelheim Pharmaceuticals…
-
EMA approval · 2024-12-03EMA Authorised: Bevespi Aerosphere (glycopyrronium;formoterol fumarate dihydrate) — AstraZeneca AB
The European Medicines Agency authorised Bevespi Aerosphere, an inhaled fixed-dose combination of glycopyrronium and formoterol fumarate dih…
-
FDA approval · 2024-11-19FDA Approved: IPRATROPIUM BROMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for ipratropium bromide, indicating updated labeling/indications for the product.
-
FDA approval · 2024-11-18FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for arformoterol tartrate, a generic long-acting beta-agonist for chronic obstructive pulmonary diseas…
-
FDA approval · 2024-11-15FDA Approved: IPRATROPIUM BROMIDE — Original Application (Advagen Pharma Ltd)
FDA approved the original application for ipratropium bromide from Advagen Pharma Ltd, granting a generic approval.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2024-10-22FDA Approved: FORMOTEROL FUMARATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved a generic formoterol fumarate product under an original application from Ingenus Pharmaceuticals, expanding access to this inha…
-
FDA approval · 2024-09-05FDA Approved: THEOPHYLLINE — Original Application (Strides Pharma Science Limited)
FDA approves a generic Theophylline from Strides Pharma Science Limited via an Original Application (ANDA).
-
EMA approval · 2024-07-24EMA Authorised: DuoResp Spiromax (Budesonide;formoterol fumarate dihydrate) — Teva Pharma B.V.
The European Medicines Agency authorised DuoResp Spiromax, a budesonide/formoterol inhaler, for the treatment of chronic obstructive pulmona…
-
EMA approval · 2024-07-24EMA Authorised: BiResp Spiromax (Budesonide;formoterol fumarate dihydrate) — Teva Pharma B.V.
The European Medicines Agency authorised BiResp Spiromax, a budesonide/formoterol inhaler from Teva Pharma B.V., for treatment of chronic ob…
-
FDA approval · 2024-07-16FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Lifestar Pharma LLC)
FDA approved a supplemental application for Formoterol Fumarate (formoterol fumarate dihydrate) from Lifestar Pharma LLC, approving an updat…
-
FDA approval · 2024-07-05FDA Approved: ARFORMOTEROL TARTRATE — Supplemental Application (Lifestar Pharma LLC)
FDA approved a supplemental application for arformoterol tartrate by Lifestar Pharma LLC, confirming approval of a generic inhalation bronch…
-
FDA approval · 2024-06-26FDA Approved: OHTUVAYRE — Original Application (Verona Pharma, Inc.)
The FDA approved OHTUVAYRE (ensifentrine) under an original application from Verona Pharma. It is indicated for the treatment of chronic obs…
-
FDA approval · 2024-06-26FDA Approved: FORMOTEROL FUMARATE — Original Application (Micro Labs Limited)
FDA approved the original application for Formoterol Fumarate from Micro Labs Limited (ANDA 218304), granting generic approval for formotero…
-
FDA approval · 2024-06-03FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approves Dr. Reddy's Laboratories' arformoterol tartrate (ARFORMOTEROL TARTRATE) under an Original Application for the inhalation soluti…
-
FDA approval · 2024-05-21FDA Approved: THEOPHYLLINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original ANDA for Theophylline by Zydus Lifesciences Limited.
-
FDA approval · 2024-05-21FDA Approved: ALBUTEROL SULFATE — Original Application (Armstrong Pharmaceuticals, Inc.)
FDA approved the original generic application for albuterol sulfate from Armstrong Pharmaceuticals, Inc. as a generic bronchodilator. It is …
-
FDA approval · 2024-05-03FDA Approved: ALBUTEROL SULFATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approves Ingenus Pharmaceuticals' original application for albuterol sulfate as a generic inhalation product. The approved indication co…
-
FDA approval · 2024-04-02FDA Approved: ARFORMOTEROL TARTRATE — Original Application (Fosun Pharma USA Inc.)
FDA approved arformoterol tartrate from Fosun Pharma USA Inc. under an original ANDA, establishing a generic maintenance inhalation bronchod…
-
FDA approval · 2023-12-19FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the supplemental application for Fluticasone Propionate and Salmeterol from Hikma Pharmaceuticals USA Inc., confirming a supple…
-
FDA approval · 2023-12-13FDA Approved: INCRUSE ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for INCRUSE ELLIPTA (umeclidinium) submitted by GlaxoSmithKline LLC. This action adds or updates…
-
FDA approval · 2023-12-05FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)
FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…
-
FDA approval · 2023-11-16FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental NDA for Fluticasone propionate and salmeterol, expanding its labeling and approved uses.
-
FDA approval · 2023-10-24FDA Approved: THEOPHYLLINE — Original Application (Harman Finochem Limited)
FDA approved Harman Finochem Limited's original application for Theophylline, enabling its generic manufacture and marketing under an ANDA O…
-
FDA approval · 2023-08-28FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)
FDA approved a supplemental application for ProAir Digihaler (albuterol sulfate) from Teva Respiratory, LLC. The approval covers changes rel…
-
FDA approval · 2023-06-23FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)
FDA approved a supplemental application for ALBUTEROL SULFATE from Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. under an ANDA for a generic p…