Original New Drug Application Approvals by US FDA (16-31 August 2024)
19 Sep 2024
New drug applications approved by US FDA as of 16-31 August 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.
LAZCLUZE
LAZCLUZE
- Active Ingredient(s): Lazertinib Mesylate
- Strength: EQ 80MG BASE; EQ 240MG BASE
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Janssen Biotech
- Approval Date: 19 August 2024
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- Approved Label: 19 August 2024 (PDF)
- Active Ingredient(s): Aflibercept-ayyh
- Strength: 2 mg (0.05 mL of 40 mg/mL)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Amgen Inc
- Approval Date: 23 August 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: 23 August 2024 (PDF)
- Active Ingredient(s): Bortezomib
- Strength: 3.5MG/1.4ML (2.5MG/ML)
- Dosage Form(s) / Route(s): Solution;intravenous, subcutaneous
- Company: Shilpa
- Approval Date: 26 August 2024
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for:
- treatment of adult patients with multiple myeloma
- treatment of adult patients with mantle cell lymphoma
- Approved Label: 26 August 2024 (PDF)
- Active Ingredient(s): Letermovir
- Strength: 20MG/PACKET; 120MG/PACKET
- Dosage Form(s) / Route(s): Pellets;oral
- Company: MSD
- Approval Date: 30 August 2024
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for:
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
- Approved Label: 30 August 2024 (PDF)