Original New Drug Application Approvals by US FDA (16-31 October 2026)
06 Nov 2026
New drug applications approved by US FDA as of 16-31 October 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
YULZETY
YULZETY
- Active Ingredient(s): Rivaroxaban
- Strength: 2MG/ML; 4MG/ML
- Dosage Form(s) / Route(s): Suspension;oral
- Company: Rosemont Pharms
- Approval Date: 16 October 2026
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated:
- to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation
- for treatment of deep vein thrombosis (DVT)
- for treatment of pulmonary embolism (PE)
- for reduction in the risk of recurrence of DVT or PE
- for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
- for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients
- for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients weighing at least 12 kg
- for thromboprophylaxis in pediatric patients, weighing at least 12 kg, with congenital heart disease after the Fontan procedure
- Approved Label: 16 October 2026 (PDF)
- Active Ingredient(s): Sodium Ctirate
- Strength: 40G/L trisodium citrate dihydrate (136MMOL/L citrate)
- Dosage Form(s) / Route(s): Solution; Injection
- Company: Fresenius Medcl Care
- Approval Date: 19 October 2026
- Submission Classification: Type 2 - New Active Ingredient
- Indication(s): Indicated for regional citrate anticoagulation (RCA) during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF) in adults and pediatric patients weighing greater than or equal to 40 kg.
- Approved Label: 19 October 2026 (PDF)
- Active Ingredient(s): Calcuim Chloride
- Strength: 14.7G/L calcium chloride dihydrate (100MMOL/L calcium)
- Dosage Form(s) / Route(s): Solution; Injection
- Company: Fresenius Medcl Care
- Approval Date: 19 October 2026
- Submission Classification: Type 2 - New Active Ingredient
- Indication(s): Indicated for calcium substitution for regional citrate anticoagulation (RCA) during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF) in adults and pediatric patients weighing greater than or equal to 40 kg.
- Approved Label: 19 October 2026 (PDF)
- Active Ingredient(s): Bepirovirsen
- Strength: NA
- Dosage Form(s) / Route(s): Injection;solution
- Company: GlaxoSmithKline LLC
- Approval Date: 20 October 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic HBV infection in adult patients without cirrhosis:
- who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and
- who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test.
- Approved Label: 20 October 2026 (PDF)
- Active Ingredient(s): Ranibizumab
- Strength: NA
- Dosage Form(s) / Route(s): Injection;solution
- Company: Xbrane Biopharma Ab
- Approval Date: 27 October 2026
- Submission Classification: NA
- Indication(s): Indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Myopic Choroidal Neovascularization (mCNV)
- Approved Label: 27 October 2026 (PDF)
- Active Ingredient(s): Cisplatin
- Strength: 1MG/ML
- Dosage Form(s) / Route(s): Liquid
- Company: Avyxa Holdings, LLC.
- Approval Date: 29 October 2026
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of:
- Advanced testicular cancer
- Advanced ovarian cancer
- Advanced bladder cancer
- Approved Label: 29 October 2026 (PDF)