Asthma
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-07-01FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for Montelukast Sodium (generic montelukast) submitted by Ajanta Pharma USA Inc. under ANDA203328.
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FDA approval · 2025-06-30FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
FDA approved a supplemental application for epinephrine from BPI Labs, LLC, confirming regulatory action on the product.
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FDA approval · 2025-06-13FDA Approved: THEOPHYLLINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Theophylline submitted by Chartwell RX, LLC.
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FDA approval · 2025-06-05FDA Approved: DULERA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) from Organon LLC. The approval upd…
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EMA approval · 2025-05-28EMA Authorised: Xolair (omalizumab) — Novartis Europharm Limited
The European Medicines Agency authorised Xolair (omalizumab) for asthma, urticaria, and rhinitis with Novartis Europharm Limited as the mark…
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FDA approval · 2025-04-16FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Montelukast sodium (generic montelukast) submitted by Amneal Pharmaceuticals LLC under ANDA20510…
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EMA approval · 2025-04-11EMA Authorised: Cinqaero (reslizumab) — Teva B.V.
The European Medicines Agency authorised Cinqaero (reslizumab) by Teva B.V. for the treatment of asthma in the European Union.
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FDA approval · 2025-04-03FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium (ANDA 201515), enabling the approval of a gen…
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FDA approval · 2025-03-26FDA Approved: THEOPHYLLINE — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s original ANDA for theophylline, a bronchodilator used to treat symptoms of asthma and chronic obstruct…
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EMA approval · 2025-03-14EMA Authorised: Revinty Ellipta (fluticasone furoate;vilanterol trifenatate) — GlaxoSmithKline Trading Services Limited
EMA authorised Revinty Ellipta, an inhaled fixed-dose combination of fluticasone furoate and vilanterol trifenatate for asthma, marketed by …
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FDA approval · 2025-03-12FDA Approved: ALBUTEROL SULFATE INHALATION SOLUTION, 0.5% — Original Application (Ritedose Pharmaceuticals, LLC)
FDA approved ALBUTEROL SULFATE INHALATION SOLUTION, 0.5% from Ritedose Pharmaceuticals under an Abbreviated New Drug Application (generic). …
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FDA approval · 2025-02-28FDA Approved: EPINEPHRINE — Supplemental Application (American Regent, Inc.)
FDA approved a supplemental application for EPINEPHRINE from American Regent, Inc., indicating an approved change to the product's labeling …
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EMA approval · 2025-02-27EMA Authorised: Fasenra (Benralizumab) — AstraZeneca AB
EMA authorised Fasenra (benralizumab) for asthma. The marketing authorisation holder is AstraZeneca AB; decision date 13/02/2025.
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EMA approval · 2025-02-18EMA Authorised: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) (Budesonide;formoterol fumarate dihydrate) — Teva Pharma B.V.
The European Medicines Agency authorised GoResp Digihaler, a budesonide/formoterol inhalation therapy by Teva Pharma B.V. (previously Budeso…
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FDA approval · 2025-02-13FDA Approved: PREDNISOLONE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental Abbreviated New Drug Application for a generic prednisolone product from PAI Holdings/PAI Pharma, signaling regu…
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FDA approval · 2025-02-11FDA Approved: FORMOTEROL FUMARATE — Original Application (Devatis, Inc.)
FDA approved the original application (ANDA) for Formoterol Fumarate Dihydrate, the generic form of Formoterol Fumarate, manufactured by Dev…
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FDA approval · 2025-01-14FDA Approved: IPRATROPIUM BROMIDE — Original Application (Advagen Pharma Ltd)
FDA approves an original application for ipratropium bromide from Advagen Pharma Ltd (ANDA 219222).
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FDA approval · 2025-01-13FDA Approved: THEOPHYLLINE — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA's Theophylline as an original (generic) application; Theophylline is a bronchodilator for reversible airway o…
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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…
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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…
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FDA approval · 2024-09-27FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for Montelukast from BluePoint Laboratories under an ANDA, resulting in regulatory approval of t…
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FDA approval · 2024-09-17FDA Approved: FASENRA — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for FASENRA (benralizumab) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2024-09-12FDA Approved: DUPIXENT — Supplemental Application (sanofi-aventis U.S. LLC)
FDA approved a supplemental application for Dupixent (dupilumab) submitted by sanofi-aventis U.S. LLC.
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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).
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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…