Original New Drug Application Approvals by US FDA (16-31 August 2025)

New drug applications approved by US FDA as of 16-31 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.

DAWNZERA (AUTOINJECTOR)

• Active Ingredient(s): Donidalorsen Sodium
• Strength: EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
• Dosage Form(s) / Route(s): Solution;subcutaneous
• Company: Ionis Pharms Inc
• Approval Date: 21 August 2025
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
• Approved Label:  21 August 2025 (PDF)

CAMCEVI ETM

• Active Ingredient(s): Leuprolide Mesylate
• Strength: EQ 21MG BASE
• Dosage Form(s) / Route(s): Emulsion;subcutaneous
• Company: Foresee Pharms
• Approval Date: 25 August 2025
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of adult patients with advanced prostate cancer.
• Approved Label:  25 August 2025 (PDF)

LOPRESSOR

• Active Ingredient(s): Metoprolol Tartrate
• Strength: 12.5MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Xtm Consulting
• Approval Date: 28 August 2025
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality.
• Approved Label:  28 August 2025 (PDF)

OTEZLA

• Active Ingredient(s): Apremilast
• Strength: 20MG; 30MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Amgen Inc
• Approval Date: 29 August 2025
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of:
• Active psoriatic arthritis
• Plaque psoriasis who are candidates for phototherapy or systemic therapy
• Oral ulcers associated with Behçet’s Disease
Pediatric patients 6 years of age and older with:
• Active psoriatic arthritis
• Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg.
• Approved Label:  29 August 2025 (PDF)

OTEZLA XR

• Active Ingredient(s): Apremilast
• Strength: 75MG
• Dosage Form(s) / Route(s): Tablet, Extended Release;oral
• Company: Amgen Inc
• Approval Date: 29 August 2025
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of:
• Active psoriatic arthritis
• Plaque psoriasis who are candidates for phototherapy or systemic therapy
• Oral ulcers associated with Behçet’s Disease
Pediatric patients 6 years of age and older with:
• Active psoriatic arthritis
• Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg.
• Approved Label:  29 August 2025 (PDF)

ESCITALOPRAM

• Active Ingredient(s): Escitalopram Oxalate
• Strength: EQ 15MG BASE
• Dosage Form(s) / Route(s): Capsule;oral
• Company: Almatica
• Approval Date: 29 August 2025
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of:
• Major depressive disorder in adults younger than 65 years of age and pediatric patients 12 years of age and older
• Generalized anxiety disorder in adults younger than 65 years of age
• Approved Label:  29 August 2025 (PDF)

WAYRILZ

• Active Ingredient(s): Rilzabrutinib
• Strength: 400MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Genzyme Corp
• Approval Date: 29 August 2025
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
• Approved Label:  29 August 2025 (PDF)

LEQEMBI IQLIK

• Active Ingredient(s): Lecanemab-irmb
• Strength: 200MG/2ML(100MG/ML); 500MG/5ML(100MG/ML)
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Eisai Inc
• Approval Date: 29 August 2025
• Submission Classification: NA
• Indication(s): Indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
• Approved Label:  29 August 2025 (PDF)

BILDYOS

• Active Ingredient(s): Denosumab-nxxp
• Strength: 60MG/ML
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Shanghai Henlius Biotech
• Approval Date: 29 August 2025
• Submission Classification: NA
• Indication(s): Indicated for:
  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
• Approved Label:  29 August 2025 (PDF)

BILPREVDA

• Active Ingredient(s): Denosumab-nxxp
• Strength: 120MG/1.7ML(70MG/ML)
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Shanghai Henlius Biotech
• Approval Date: 29 August 2025
• Submission Classification: NA
• Indication(s): Indicated for:
  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
• Approved Label:  29 August 2025 (PDF)