Original New Drug Application Approvals by US FDA (16-31 March 2025) | Multidisciplinary

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

HEMICLOR

Active Ingredient(s): Chlorthalidone
Strength: 75MG/0.5ML; 12.5MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Prm Pharma
Approval Date: 17 March 2025
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Approved Label: 17 March 2025 (PDF)

GOZELLIX

Active Ingredient(s): Kit For The Preparation Of Gallium Ga 68 Gozetotide
Strength: 25UG/1VIAL
Dosage Form(s) / Route(s): Injection, Powder, Lyophilized, For Solution
Company: Telix Innovations Sa
Approval Date: 20 March 2025
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

With suspected metastasis who are candidates for initial definitive therapy.
With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Approved Label: 20 March 2025 (PDF)

BLUJEPA

Active Ingredient(s): Gepotidacin Mesylate
Strength: 750MG
Dosage Form(s) / Route(s): Tablet
Company: Glaxosmithkline Llc
Approval Date: 25 March 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
Approved Label: 25 March 2025 (PDF)

BOMYNTRA

Active Ingredient(s): Denosumab-bnht
Strength: 120MG/1.7ML (70 MG/ML)
Dosage Form(s) / Route(s): Injection
Company: Fresenius Kabi Usa Llc
Approval Date: 25 March 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: 25 March 2025 (PDF)

CONEXXENCE

Active Ingredient(s): Denosumab-bnht
Strength: 60MG/ML
Dosage Form(s) / Route(s): Injection
Company: Fresenius Kabi Usa Llc
Approval Date: 25 March 2025
Submission Classification: NA
Indication(s): Indicated for treatment:

of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Approved Label: 25 March 2025 (PDF)

DENOSUMAB-BNHT

Active Ingredient(s): Denosumab-bnht
Strength: 120MG/1.7ML (70 MG/ML); 60MG/ML
Dosage Form(s) / Route(s): Injection
Company: Fresenius Kabi Usa Llc
Approval Date: 25 March 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: 25 March 2025 (PDF)

VYKAT XR

Active Ingredient(s): Diazoxide Choline
Strength: 25MG; 75MG; 150MG
Dosage Form(s) / Route(s): Tablet, Extended Release;oral
Company: Soleno Therapeutics Inc
Approval Date: 26 March 2025
Submission Classification: Type 2 - New Active Ingredient
Indication(s): Indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
Approved Label: 26 March 2025 (PDF)

QFITLIA

Active Ingredient(s): Fitusiran Injection
Strength: 20MG/0.2ML; 50MG/0.5ML
Dosage Form(s) / Route(s): Injection
Company: Genzyme Corp
Approval Date: 28 March 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
Approved Label: 28 March 2025 (PDF)