Original New Drug Application Approvals by US FDA (16-31 July 2026)
02 Sep 2026
New drug applications approved by US FDA as of 16-31 July 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.
JIDEYTRO
JIDEYTRO
- Active Ingredient(s): Zidesamtinib
- Strength: 25MG; 100MG
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: Nuvalent INC
- Approval Date: 22 July 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.
- Approved Label: 22 July 2026 (PDF)
- Active Ingredient(s): Centanafadine Hydrochloride
- Strength: 280MG
- Dosage Form(s) / Route(s): Capsule, Extended Release
- Company: Otsuka Pharmaceutical Co LTD
- Approval Date: 24 July 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older weighing at least 20 kg.
Limitations of Use
The use of SIMTRIYO is not recommended in pediatric patients:- Younger than 6 years of age because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older.
- Weighing less than 20 kg because of a lack of data for this subpopulation and the risk of weight loss.
- Approved Label: 24 July 2026 (PDF)
- Active Ingredient(s): Bevacizumab-vikg
- Strength: 1.25MG (0.05ML of 25MG/ML
- Dosage Form(s) / Route(s): Vial;single-dose
- Company: Outlook Therapeutics, INC.
- Approval Date: 24 July 2026
- Submission Classification: NA
- Indication(s): Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).
- Approved Label: 24 July 2026 (PDF)
- Active Ingredient(s): Insulin Aspart-fsan
- Strength: 3ML
- Dosage Form(s) / Route(s): Pen;prefilled
- Company: Emerge Bioscience Pte. LTD.
- Approval Date: 24 July 2026
- Submission Classification: NA
- Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- Approved Label: 24 July 2026 (PDF)
- Active Ingredient(s): Insulin Aspart-fsan
- Strength: 10ML
- Dosage Form(s) / Route(s): Vial; Multidose
- Company: Emerge Bioscience Pte. LTD.
- Approval Date: 24 July 2026
- Submission Classification: NA
- Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- Approved Label: 24 July 2026 (PDF)
- Active Ingredient(s): Sodium Glycerophosphate
- Strength: 1MMOL/ML
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Fresenius Kabi USA LLC
- Approval Date: 29 July 2026
- Submission Classification: Type 2 - New Active Ingredient
- Indication(s): Indicated as a source of phosphorus in adults and pediatric patients 12 years and older as part of parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
- Approved Label: 29 July 2026 (PDF)
- Active Ingredient(s): Clonidine Hydrochloride
- Strength: 0.05MG/ML
- Dosage Form(s) / Route(s): Solution;oral
- Company: Cmp Dev LLC
- Approval Date: 29 July 2026
- Submission Classification: Type 5 - New Formulation or New Manufacture
- Indication(s): Indicated for the treatment of hypertension, to lower blood pressure in adults. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be employed alone or concomitantly with other antihypertensive agents.
- Approved Label: 29 July 2026 (PDF)
