Asthma
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Sign up freeTop drugs studied for this disease
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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…
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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…
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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…
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FDA approval · 2024-05-21FDA Approved: THEOPHYLLINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original ANDA for Theophylline by Zydus Lifesciences Limited.
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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 …
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FDA approval · 2024-05-17FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., authorizing its generic montelukast pr…
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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…
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FDA approval · 2024-04-05FDA Approved: FASENRA — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for FASENRA (benralizumab) from AstraZeneca.
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FDA approval · 2024-01-25FDA Approved: DUPIXENT — Supplemental Application (sanofi-aventis U.S. LLC)
FDA approved a supplemental application for Dupixent (dupilumab) filed by Sanofi‑Aventis U.S. LLC, indicating an approval of a supplement re…
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FDA approval · 2024-01-05FDA Approved: DEXAMETHASONE INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for DEXAMETHASONE INTENSOL from Hikma Pharmaceuticals USA, Inc., a dexamethasone product.
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FDA approval · 2023-12-28FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
The FDA has approved a supplemental application for epinephrine filed by BPI Labs, LLC under the existing NDA. The approval authorizes chang…
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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…
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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…
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FDA approval · 2023-11-27FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for montelukast sodium from Dr. Reddy's Laboratories Limited, representing an additional approva…
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FDA approval · 2023-11-27FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited under an ANDA, enabling a supplemental …
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FDA approval · 2023-11-27FDA Approved: ZAFIRLUKAST — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for Zafirlukast from Aurobindo Pharma Limited, providing a generic option for asthma.
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FDA approval · 2023-11-21FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approves Accord Healthcare Inc.'s Montelukast Sodium supplemental application for the generic product, enabling its labeling and market …
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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.
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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…
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FDA approval · 2023-10-02FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)
The FDA approved Westminster Pharmaceuticals, LLC's supplemental application for Montelukast Sodium, a generic product under an ANDA.
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FDA approval · 2023-09-21FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Montelukast from XLCare Pharmaceuticals Inc., authorizing a supplemental action related to a…
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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…
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FDA approval · 2023-07-31FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium from Macleods Pharmaceuticals Limited, authorizing continued marketing of thi…
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FDA approval · 2023-06-28FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental ANDA for Montelukast Sodium by Unichem Pharmaceuticals (USA), Inc., granting approval for its generic product. M…
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FDA approval · 2023-06-28FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental ANDA for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., adding a generic Montelukast Sodium produc…