FDA updates for February include a longer treatment duration for Izervay, a new tablet formulation for Evrysdi and approval of Gomekli, a MEK inhibitor to treat the rare genetic disorder neurofibromatosis. FDA also cleared Onapgo in Parkinson’s disease OFF episodes, Emblaveo for complicated intra-abdominal infections and Miudella, a low-dose copper-containing IUD. Ospomyv, Xbryk and Merilog are the latest biosimilars, plus Penmenvy is a pentavalent meningococcal vaccine, and Romvimza and Ctexli are approved in rare diseases.
Featured News FDA updates for February include a longer treatment duration for Izervay, a new tablet formulation for Evrysdi and approval of Gomekli, a MEK inhibitor to treat the rare genetic disorder neurofibromatosis. FDA also cleared Onapgo in Parkinson’s disease OFF episodes, Emblaveo for complicated intra-abdominal infections and Miudella, a low-dose copper-containing IUD. Ospomyv, Xbryk and Merilog are the latest biosimilars, plus Penmenvy is a pentavalent meningococcal vaccine, and Romvimza and Ctexli are approved in rare diseases.
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New Drug Approvals The following drugs have recently been approved by the FDA. - Miudella (copper) Intrauterine System
Date of Approval: February 24, 2025 Treatment for: Birth Control Press Release | Approval History
- Ctexli (chenodiol) Tablets
Date of Approval: February 21, 2025 Treatment for: Cerebrotendinous Xanthomatosis Press Release | Approval History
- Romvimza (vimseltinib) Capsules
Date of Approval: February 14, 2025 Treatment for: Tenosynovial Giant Cell Tumor Press Release | Approval History
- Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection
Date of Approval: February 14, 2025 Treatment for: Meningococcal Disease Prophylaxis Press Release | Approval History
- Vimkunya (chikungunya vaccine, recombinant) Injection
Date of Approval: February 14, 2025 Treatment for: Chikungunya Disease Prevention Press Release | Approval History
- Merilog (insulin aspart-szjj) Injection
Date of Approval: February 14, 2025 Treatment for: Diabetes Mellitus Press Release | Approval History
- Ospomyv (denosumab-dssb) Injection
Date of Approval: February 13, 2025 Treatment for: Osteoporosis Press Release | Approval History
- Xbryk (denosumab-dssb) Injection
Date of Approval: February 13, 2025 Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy Press Release | Approval History
- Gomekli (mirdametinib) Capsules and Tablets for Oral Suspension
Date of Approval: February 11, 2025 Treatment for: Neurofibromatosis Press Release | Approval History
- Emblaveo (avibactam and aztreonam) Lyophilized Powder for Injection
Date of Approval: February 7, 2025 Treatment for: Intraabdominal Infection Press Release | Approval History
- Onapgo (apomorphine hydrochloride) Subcutaneous Infusion Device
Date of Approval: February 3, 2025 Treatment for: Parkinson's Disease 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. - Bosentan Tablets for Oral Suspension
32 mg
Approved: February 5, 2025 - Natco Pharma USA LLC
Treatment for: Pulmonary Arterial Hypertension
Generic for:
Tracleer Tablets for Oral Suspension
- Gadoteridol Injection
279.3 mg/mL
Approved: February 11, 2025 - Hainan Poly Pharm Co., Ltd.
Treatment for: Magnetic Resonance Imaging
Generic for:
ProHance
- Mercaptopurine Oral Suspension
20 mg/mL
Approved: February 26, 2025 - Hikma Pharmaceuticals USA Inc.
Treatment for: Acute Lymphoblastic Leukemia
Generic for:
Purixan
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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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