Original-New-Drug-Application-Approvals-by-US-FDA--1-15-June-2025

New drug applications approved by US FDA as of 1-15 June 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.

XIFYRM

• Active Ingredient(s): Meloxicam
• Strength: 30MG/ML (30MG/ML)
• Dosage Form(s) / Route(s): Solution;intravenous
• Company: Azurity
• Approval Date: 5 June 2025
• Submission Classification: NA
• Indication(s): Indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
Limitations of Use
Because of delayed onset of analgesia, XIFYRM alone is not recommended for use when rapid onset of analgesia is required.
• Approved Label:  5 June 2025 (PDF)

WIDAPLIK

• Active Ingredient(s): Amlodipine Besylate; Indapamide; Telmisartan
• Strength: EQ 1.25MG BASE;0.625MG;10MG, EQ 2.5MG BASE;1.25MG;20MG, EQ 5MG BASE;2.5MG;40MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: George Medicines
• Approval Date: 5 June 2025
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Approved Label:  5 June 2025 (PDF)

ROCURONIUM BROMIDE

• Active Ingredient(s): Rocuronium Bromide
• Strength: 50MG/5ML (10MG/ML), 100MG/10ML (10MG/ML)
• Dosage Form(s) / Route(s): Solution;intravenous
• Company: Fresenius Kabi Usa
• Approval Date: 9 June 2025
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
• Approved Label:  9 June 2025 (PDF)

ENFLONSIA

• Active Ingredient(s): Clesrovimab-cfor
• Strength: 105MG/0.7ML
• Dosage Form(s) / Route(s): Injection;solution
• Company: Merck Sharp Dohme
• Approval Date: 9 June 2025
• Submission Classification: NA
• Indication(s): Indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.
• Approved Label:  9 June 2025 (PDF)

BRUKINSA

• Active Ingredient(s): Zanubrutinib
• Strength: 160MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Beone Medicines Usa
• Approval Date: 10 June 2025
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of adult patients with:
• Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Waldenström’s macroglobulinemia (WM).
• Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Approved Label:  10 June 2025 (PDF)

BRUKINSA

• Active Ingredient(s): Zanubrutinib
• Strength: 80MG
• Dosage Form(s) / Route(s): Capsule;Oral
• Company: Beone Medicines Usa
• Approval Date: 10 June 2025
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of adult patients with:
• Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Waldenström’s macroglobulinemia (WM).
• Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Approved Label:  10 June 2025 (PDF)

IBTROZI

• Active Ingredient(s): Taletrectinib Adipate
• Strength: EQ 200MG BASE
• Dosage Form(s) / Route(s): Capsule;Oral
• Company: Nuvation
• Approval Date: 11 June 2025
• 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).
• Approved Label:  11 June 2025 (PDF)

ZUSDURI

• Active Ingredient(s): Mitomycin
• Strength: 40MG/VIAL
• Dosage Form(s) / Route(s): Powder, Intravesical
• Company: Urogen Pharma
• Approval Date: 12 June 2025
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
• Approved Label:  12 June 2025 (PDF)