In November, the FDA cleared UCB’s Bimzelx for hidradenitis suppurativa, Emrosi capsule for rosacea, and Danziten, the first nilotinib medicine without mealtime restrictions. Aucatzyl is cleared for ALL, an aggressive blood cancer, and Kebilidi is a gene replacement therapy administered directly into the brain. Additional approvals are first-in-class oral Revuforj for leukemia, Ziihera for biliary tract cancer, Attruby for cardiomyopathy, an oral imatinib solution called Imkeldi and Rapiblyk to treat an abnormally rapid heart rate.
Featured News In November, the FDA cleared UCB’s Bimzelx for hidradenitis suppurativa, Emrosi capsule for rosacea, and Danziten, the first nilotinib medicine without mealtime restrictions. Aucatzyl is cleared for ALL, an aggressive blood cancer, and Kebilidi is a gene replacement therapy administered directly into the brain. Additional approvals are first-in-class oral Revuforj for leukemia, Ziihera for biliary tract cancer, Attruby for cardiomyopathy, an oral imatinib solution called Imkeldi and Rapiblyk to treat an abnormally rapid heart rate.
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New Drug Approvals The following drugs have recently been approved by the FDA. - Attruby (acoramidis) Tablets
Date of Approval: November 22, 2024 Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis Press Release | Approval History
- Imkeldi (imatinib mesylate) Oral Solution
Date of Approval: November 22, 2024 Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Diseases, Myeloproliferative Disorders, Systemic Mastocytosis, Hypereosinophilic Syndrome, Chronic Eosinophilic Leukemia, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor Press Release | Approval History
- Rapiblyk (landiolol) Lyophilized Powder for Injection
Date of Approval: November 22, 2024 Treatment for: Supraventricular Tachycardia Press Release | Approval History
- Ziihera (zanidatamab-hrii) Lyophilized Powder for Injection
Date of Approval: November 20, 2024 Treatment for: Biliary Tract Tumor Press Release | Approval History
- Revuforj (revumenib) Tablets
Date of Approval: November 15, 2024 Treatment for: Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia Press Release | Approval History
- Kebilidi (eladocagene exuparvovec-tneq) Suspension for Intraputaminal Infusion
Date of Approval: November 13, 2024 Treatment for: AADC Deficiency Press Release | Approval History
- Aucatzyl (obecabtagene autoleucel) Suspension for Intravenous Infusion
Date of Approval: November 8, 2024 Treatment for: Acute Lymphoblastic Leukemia Press Release | Approval History
- Danziten (nilotinib tartrate) Tablets
Date of Approval: November 7, 2024 Treatment for: Chronic Myelogenous Leukemia Press Release | Approval History
- Emrosi (minocycline hydrochloride) Extended-Release Capsules
Date of Approval: November 1, 2024 Treatment for: Rosacea Press Release | Approval History
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New Indications and Dosage Forms Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
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First-Time Generic Approvals First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace. - Exenatide Injection
300 mcg/1.2 mL (250 mcg/mL) and 600 mcg/2.4 mL (250 mcg/mL)
Approved: November 19, 2024 - Amneal Pharmaceuticals LLC
Treatment for: Type 2 Diabetes
Generic for:
Byetta
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This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party websites. The Editorial Team, Drugs.com
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