Original New Drug Application Approvals by US FDA (16 - 31 August 2022)
05 Sep 2022
New drug applications approved by US FDA as of 16 - 31 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.
AUVELITY
AUVELITY
- Active Ingredient(s): Bupropion Hydrochloride; Dextromethorphan Hydrobromide
- Strength: 105MG;45MG
- Dosage Form(s) / Route(s): Tablet, Extended Release;Oral
- Company: Axsome
- Approval Date: 18 August 2022
- Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
- Indication(s): Indicated for the treatment of major depressive disorder (MDD) in adults.
- Approved Label: 18 August (PDF)
- Active Ingredient(s): Ibrutinib
- Strength: 70MG/ML; 70MG; 140MG; 230MG; 420MG; 560MG
- Dosage Form(s) / Route(s): Suspension;Oral; Capsule;Oral; Tablet;Oral
- Company: Pharmacyclics Inc
- Approval Date: 24 August 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- 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 a confirmatory trial(s). - Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
- Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
- Adult patients with Waldenström’s macroglobulinemia (WM).
- Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based 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 a confirmatory trial(s). - Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
- Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Approved Label: 24 August 2022 (PDF)
- Active Ingredient(s): Omeprazole And Sodium Bicarbonate
- Strength: 2MG; 84MG / ML
- Dosage Form(s) / Route(s): Suspension;Oral
- Company: Azurity Pahrmaceuticals, Inc
- Approval Date: 31 August 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated in adults for:
- Treatment of active benign gastric ulcer.
- Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.
- Approved Label: 31 August (PDF)
