(JM test 1)Original New Drug Application Approvals by US FDA (1-15 March 2024)
22 Jul 2024
New drug applications approved by US FDA as of 1-15 March 2024 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.
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE
- Active Ingredient(s): Clobetasol Propionate
- Strength: 0.05%
- Dosage Form(s) / Route(s): Suspension/drops;ophthalmic
- Company: Formosa Pharmaceuticals Inc
- Approval Date: 04 March 2024
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of post-operative inflammation and pain following ocular surgery.
- Approved Label: 04 March 2024 (PDF)
- Active Ingredient(s): Tocilizumab-aazg
- Strength: 162MG/0.9ML,80MG/4ML,200MG/10ML,400MG/20ML
- Dosage Form(s) / Route(s): Injectable;subcutaneous,Injectable;intravenous
- Company: Fresenius Kabi Usa
- Approval Date: 05 March 2024
- Submission Classification: Not Available
- Indication(s): Indicated for treatment of:
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Rheumatoid Arthritis (RA)
- Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA)
- Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA)
- Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
- Approved Label: 05 March 2024 (PDF)
- Active Ingredient(s): Denosumab-bbdz
- Strength: 60MG/ML
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Sandoz Inc
- Approval Date: 05 March 2024
- Submission Classification: Not Available
- Indication(s): Indicated for:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture.
- Treatment to increase bone mass in men with osteoporosis at high risk for fracture.
- Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
- Treatment to increase bone mass in women at high risk for fracturereceiving adjuvant aromatase inhibitor therapy for breast cancer.
- Approved Label: 05 March 2024 (PDF)
- Active Ingredient(s): Denosumab-bbdz
- Strength: 120MG/1.7ML (70MG/ML)
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: Sandoz Inc
- Approval Date: 05 March 2024
- Submission Classification: Not Available
- 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: 05 March 2024 (PDF)
- Active Ingredient(s): Talazoparib
- Strength: 0.1MG,0.25MG,0.35MG,0.5MG,0.75MG,1MG
- Dosage Form(s) / Route(s): Capsule; Oral
- Company: Pfizer Inc
- Approval Date: 07 March 2024
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for:
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Breast Cancer
- As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. HRR Gene-Mutated mCRPC
- In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
- Approved Label: 07 March 2024 (PDF)
- Active Ingredient(s):Tislelizumab
- Strength:100MG/10ML
- Dosage Form(s) / Route(s):Injection;solution
- Company: Beigene
- Approval Date: 13 March 2024
- Submission Classification: Not Available
- Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
- Approved Label: 13 March 2024 (PDF)
- Active Ingredient(s): Resmetirom
- Strength:60MG, 80MG, 100MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Madrigal Pharmaceuticals Inc
- Approval Date: 14 March 2024
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitations of Use
Avoid use of REZDIFFRA in patients with decompensated cirrhosis. - Approved Label: 14 March 2024 (PDF)
- Active Ingredient(s): Rilpivirine
- Strength: 25MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Janssen Prods
- Approval Date: 15 March 2024
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
Limitations of Use:- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
- Approved Label: 15 March 2024 (PDF)