Original New Drug Application Approvals by US FDA (1-15 February 2025)
10 Mar 2025
New drug applications approved by US FDA as of 1-15 February 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.
ONAPGO
ONAPGO
- Active Ingredient(s): Apomorphine Hydrochloride
- Strength: 98MG/20ML(4.9MG/ML)
- Dosage Form(s) / Route(s): Solution;subcutaneous
- Company: Mdd Us
- Approval Date: 3 February 2025
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
- Approved Label: 3 February 2025 (PDF)
- Active Ingredient(s): Avibactam Sodium; Aztreonam
- Strength: EQ 0.5GM BASE/VIAL;1.5GM/VIAL
- Dosage Form(s) / Route(s): Powder;intravenous
- Company: Abbvie
- Approval Date: 7 February 2025
- Submission Classification: Type 4 - New Combination
- Indication(s): Indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.
Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO.
Usage to Reduce Development of Drug-Resistant Bacteria
To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. - Approved Label: 7 February 2025 (PDF)
- Active Ingredient(s): Risdiplam
- Strength: 5 MG
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: Genentech Inc
- Approval Date: 11 February 2025
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients).
- Approved Label: 11 February 2025 (PDF)
- Active Ingredient(s): Mirdametinib
- Strength: 1 MG
- Dosage Form(s) / Route(s): Tablet; oral
- Company: Springworks
- Approval Date: 11 February 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
- Approved Label: 11 February 2025 (PDF)
- Active Ingredient(s): Denosumab-dssb
- Strength: 60MG/ML; 70MG/ML
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Samsung Bioepis Co Ltd
- Approval Date: 13 February 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: 13 February 2025 (PDF)
- Active Ingredient(s): Denosumab-dssb
- Strength: 60MG/ML
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Samsung Bioepis Co Ltd
- Approval Date: 13 February 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: 13 February 2025 (PDF)
- Active Ingredient(s): Denosumab-dssb
- Strength: 70MG/ML
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Samsung Bioepis Co Ltd
- Approval Date: 13 February 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: 13 February 2025 (PDF)
- Active Ingredient(s): Vimseltinib
- Strength: 14MG; 20MG; 30MG
- Dosage Form(s) / Route(s): Capsule; Oral
- Company: Deciphera Pharms
- Approval Date: 14 February 2025
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
- Approved Label: 14 February 2025 (PDF)
- Active Ingredient(s): Insulin Aspart-szjj
- Strength: 10ML(100UNITS/ML)
- Dosage Form(s) / Route(s): Injection;solution
- Company: Sanofi-aventis U.s. Llc
- Approval Date: 14 February 2025
- Submission Classification: NA
- Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- Approved Label: 14 February 2025 (PDF)
- Active Ingredient(s): Insulin Aspart-szjj
- Strength: 3ML(100UNITS/ML)
- Dosage Form(s) / Route(s): Injection;solution
- Company: Sanofi-aventis U.s. Llc
- Approval Date: 14 February 2025
- Submission Classification: NA
- Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- Approved Label: 14 February 2025 (PDF)
