Original New Drug Application Approvals by US FDA (16-31 May 2024)
10 Jun 2024
New drug applications approved by US FDA as of 16-31 May 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.
IMDELLTRA
IMDELLTRA
- Active Ingredient(s): Tarlatamab-dlle
- Strength: 1MG, 10MG
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Amgen Inc
- Approval Date: 16 May 2024
- Submission Classification: NA
- Indication(s): Indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Approved Label: 16 May 2024 (PDF)
- Active Ingredient(s): Aflibercept-jbvf
- Strength: 2MG(0.05ML,40MG/ML)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Biocon Biologics Inc
- Approval Date: 20 May 2024
- Submission Classification: NA
- Indication(s): Indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Approved Label: 20 May 2024 (PDF)
- Active Ingredient(s): Aflibercept-yszy
- Strength: 2MG(0.05ML,40MG/ML)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Samsung Bioepis Co Ltd
- Approval Date: 20 May 2024
- Submission Classification: NA
- Indication(s): Indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Approved Label: 20 May 2024 (PDF)
- Active Ingredient(s): Clonidine Hydrochloride
- Strength: NA
- Dosage Form(s) / Route(s): Suspension;extended Release
- Company: Tris Pharma Inc
- Approval Date: 24 May 2024
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
- Approved Label: 24 May 2024 (PDF)
- Active Ingredient(s): Eculizumab-aeeb
- Strength: 300MG/30ML(10MG/ML)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Amgen Inc
- Approval Date: 28 May 2024
- Submission Classification: NA
- Indication(s): Indicated for:
- The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
- The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitations of Use
- Approved Label: 28 May 2024 (PDF)
BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).