Featured News In March, the FDA cleared several new indications: Tremfya for Crohn’s disease, Amvuttra to reduce heart-related death in ATTR-CM, and Imfinzi to treat muscle invasive bladder cancer. GSK’s first-in-class Blujepa is approved for uncomplicated UTIs, Celltrion’s Omlyclo is a new interchangeable biosimilar to Xolair, and Arbli is the first losartan, shelf-stable oral suspension. Other approvals include: Encelto for Macular Telangiectasia Type 2, Vykat XR for hyperphagia in Prader-Willi Syndrome and Sanofi’s Qfitlia for hemophilia.
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New Drug Approvals The following drugs have recently been approved by the FDA. - Qfitlia (fitusiran) Injection
Date of Approval: March 28, 2025 Treatment for: Hemophilia A, Hemophilia A with Inhibitors, Hemophilia B, Hemophilia B with Inhibitors Press Release | Approval History
- Vykat XR (diazoxide choline) Extended-Release Tablets
Date of Approval: March 26, 2025 Treatment for: Prader-Willi Syndrome Press Release | Approval History
- Blujepa (gepotidacin) Tablets
Date of Approval: March 25, 2025 Treatment for: Urinary Tract Infection Press Release | Approval History
- Conexxence (denosumab-bnht) Injection
Date of Approval: March 25, 2025 Treatment for: Osteoporosis Press Release | Approval History
- Bomyntra (denosumab-bnht) Injection
Date of Approval: March 25, 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
- Gozellix (gallium Ga 68 gozetotide) Injection Kit
Date of Approval: March 20, 2025 Treatment for: Positron Emission Tomography Imaging Press Release | Approval History
- Arbli (losartan potassium) Oral Suspension
Date of Approval: March 13, 2025 Treatment for: High Blood Pressure, Diabetic Kidney Disease Press Release | Approval History
- Omlyclo (omalizumab-igec) Injection
Date of Approval: March 7, 2025 Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria Press Release | Approval History
- Encelto (revakinagene taroretcel-lwey) Intravitreal Implant
Date of Approval: March 5, 2025 Treatment for: Macular Telangiectasia Type 2 Press Release | Approval History
- Stoboclo (denosumab-bmwo) Injection
Date of Approval: February 28, 2025 Treatment for: Osteoporosis Press Release | Approval History
- Osenvelt (denosumab-bmwo) Injection
Date of Approval: February 28, 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
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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. - Neffy (epinephrine) Nasal Spray
Approval: March 5, 2025 Now Approved: 1 mg Nasal Spray for Pediatric Patients Weighing 15 to < 30 Kilograms Press Release | Approval History
- Tevimbra (tislelizumab-jsgr) Injection
Approval: March 4, 2025 Now Approved for: First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy Press Release | Approval History
- Fabhalta (iptacopan) Capsules
Approval: March 20, 2025 Now Approved for: C3 Glomerulopathy Press Release | Approval History
- Furoscix (furosemide) Injection
Approval: March 6, 2025 Now Approved for: Edema in Patients with Chronic Kidney Disease Press Release | Approval History
- Amvuttra (vutrisiran) Injection
Approval: March 20, 2025 Now Approved for: ATTR Amyloidosis with Cardiomyopathy (ATTR-CM) Press Release | Approval History
- Pluvicto (lutetium lu 177 vipivotide tetraxetan) Injection
Approval: March 28, 2025 Now Approved for: Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer Press Release | Approval History
- Jynneos (smallpox and mpox vaccine) Injection
Approval: March 31, 2025 Now Approved: Freeze-Dried Formulation Press Release | Approval History
- Tremfya (guselkumab) Injection
Approval: March 20, 2025 Now Approved for: Crohn’s Disease Press Release | Approval History
- Imfinzi (durvalumab) Injection
Approval: March 28, 2025 Now Approved for: Muscle Invasive Bladder Cancer Press Release | Approval History
- Cabometyx (cabozantinib) Tablets
Approval: March 26, 2025 Now Approved for: Neuroendocrine Tumors Press Release | Approval History
- Iluvien (fluocinolone acetonide) Intravitreal Implant
Approval: March 12, 2025 Now Approved for: Chronic Non-Infectious Uveitis Affecting the Posterior Segment Press Release | Approval History
- Keytruda (pembrolizumab) for Injection
Approval: March 19, 2025 Now Approved: Full Approval for First-Line Combination Treatment of HER2-positive Gastric or GEJ Adenocarcinoma Expressing PD-L1 Press Release | Approval History
- Egrifta WR (tesamorelin) Injection
Approval: March 25, 2025 Now Approved: Egrifta WR (tesamorelin F8) Press Release | Approval History
- Soliris (eculizumab) Injection
Approval: February 28, 2025 Now Approved for: Pediatric Patients Aged Six Years and Older Press Release | Approval History
- TNKase (tenecteplase) Lyophilized Powder for Injection
Approval: February 28, 2025 Now Approved for: Acute Ischemic Stroke in Adults Press Release | Approval History
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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. - Rivaroxaban Tablets
2.5 mg
Approved: March 3, 2025 - Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.
Treatment for: Treatment and Prevention of Blood Clots
Generic for:
Xarelto 2.5 mg
- Pralatrexate Injection
20 mg/1 mL and 40 mg/2 mL
Approved: March 10, 2025 - Dr. Reddy's Laboratories Limited
Treatment for: Peripheral T-Cell Lymphoma
Generic for:
Folotyn
- Eluxadoline Tablets
75 mg and 100 mg
Approved: March 14, 2025 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Irritable Bowel Syndrome with Diarrhea (IBS-D)
Generic for:
Viberzi
- Apalutamide Tablets
60 mg
Approved: March 17, 2025 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Prostate Cancer
Generic for:
Erleada 60 mg
- Bimatoprost Ophthalmic Solution
0.01%
Approved: March 17, 2025 - Mankind Pharma Limited
Treatment for: Glaucoma
Generic for:
Lumigan
- Lidocaine Topical Patch
1.8%
Approved: March 25, 2025 - Aveva Drug Delivery Systems Inc.
Treatment for: Post-Herpetic Neuralgia
Generic for:
ZTlido
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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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