Original-New-Drug-Application-Approvals-by-US-FDA--1-15-August-2025
22 Sep 2025
New drug applications approved by US FDA as of 1-15 August 2025 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.
E-Z-DISK
E-Z-DISK
- Active Ingredient(s): Barium Sulfate
- Strength: 700MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Bracco
- Approval Date: 1 August 2025
- Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
- Indication(s): Indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.
- Approved Label: 1 August 2025 (PDF)
- Active Ingredient(s): Dordaviprone Hydrochloride
- Strength: EQ 125MG BASE
- Dosage Form(s) / Route(s): Capsule;oral
- Company: Chimerix
- Approval Date: 6 August 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - Approved Label: 6 August 2025 (PDF)
- Active Ingredient(s): Zongertinib
- Strength: 60MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Boehringer Ingelheim
- Approval Date: 8 August 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - Approved Label: 8 August 2025 (PDF)
- Active Ingredient(s): Carboplatin
- Strength: 20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 500MG/50ML (10MG/ML)
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Avyxa Holdings
- Approval Date: 8 August 2025
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated in adults:
- As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.
- As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy.
- Approved Label: 8 August 2025 (PDF)
- Active Ingredient(s): Brensocatib
- Strength: 10MG; 25MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Insmed Inc
- Approval Date: 12 August 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.
- Approved Label: 12 August 2025 (PDF)
- Active Ingredient(s): Articaine Hydrochloride
- Strength: EQ 8% BASE
- Dosage Form(s) / Route(s): Solution/drops;ophthalmic
- Company: Am Genomics
- Approval Date: 15 August 2025
- Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
- Indication(s): Indicated for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients.
- Approved Label: 15 August 2025 (PDF)