Original New Drug Application Approvals by US FDA (01 - 15 August 2022)
15 Aug 2022
New drug applications approved by US FDA as of 01 - 15 August 2022 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.
CIMERLI
CIMERLI
- Active Ingredient(s): Ranibizumab-EQRN
- Strength: 0.3MG(6MG/ML), 0.5MG(10MG/ML)
- Dosage Form(s) / Route(s): Injectable;Injection
- Company: Coherus Biosciences Inc
- Approval Date: 02 August 2022
- 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)
- Myopic Choroidal Neovascularization (mCNV)
- Approved Label: 02 August (PDF)
- Active Ingredient(s): Acalabrutinib
- Strength: 100MG
- Dosage Form(s) / Route(s): Tablet, Film Coated
- Company: Astrazeneca Uk Ltd
- Approval Date: 03 August 2022
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of adult patients with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Approved Label: 03 August 2022 (PDF)
- Active Ingredient(s): MIDAZOLAM
- Strength: 10MG/0.7ML
- Dosage Form(s) / Route(s): Injectable;Autoinjector
- Company: Rafa Labs Ltd
- Approval Date: 08 August 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of status epilepticus in adults.
- Approved Label: 08 August (PDF)
