January FDA approvals include the novel, first-in-class non-opioid pain treatment Journavx, plus Ozempic is the first approved GLP-1 agonist to reduce chronic kidney disease in adults with type 2 diabetes. Additional advances include metastatic breast cancer treatments Enhertu and Datroway, Calquence for mantle cell lymphoma, and Lilly’s Omvoh, now indicated for Crohn’s disease. Alzheimer’s treatment Leqembi offers a new dosing schedule and additional approvals include Spravato, Lumakras, and Grafapex.
Featured News January FDA approvals include the novel, first-in-class non-opioid pain treatment Journavx, plus Ozempic is the first approved GLP-1 agonist to reduce chronic kidney disease in adults with type 2 diabetes. Additional advances include metastatic breast cancer treatments Enhertu and Datroway, Calquence for mantle cell lymphoma, and Lilly’s Omvoh, now indicated for Crohn’s disease. Alzheimer’s treatment Leqembi offers a new dosing schedule and additional approvals include Spravato, Lumakras, and Grafapex.
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New Drug Approvals The following drugs have recently been approved by the FDA.
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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. - Mesna Tablets
400 mg
Approved: January 13, 2025 - Riconpharma LLC
Treatment for: Hemorrhagic Cystitis Prophylaxis
Generic for:
Mesnex Tablets
- Eltrombopag Olamine Tablets
12.5 mg (free acid), 25 mg (free acid), 50 mg (free acid) and 75 mg (free acid)
Approved: January 17, 2025 - Hetero Labs Limited, Unit V
Treatment for: Thrombocytopenia, Aplastic Anemia
Generic for:
Promacta Tablets
- Azilsartan Medoxomil and Chlorthalidone Tablets
40 mg/12.5 mg and 40 mg/25 mg
Approved: January 21, 2025 - Alkem Laboratories Limited
Treatment for: Hypertension
Generic for:
Edarbyclor
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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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