Original New Drug Application Approvals by US FDA (16 - 31 July 2022)
31 Jul 2022
New drug applications approved by US FDA as of 16 - 31 July 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.
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
- Active Ingredient(s): Midazolam
- Strength: 50MG/50ML (1MG/ML), 100MG/100ML (1MG/ML)
- Dosage Form(s) / Route(s): Solution;Intravenous
- Company: Exela Pharma
- Approval Date: 20 July 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
- Approved Label: 20 July 2022 (PDF)
- Active Ingredient(s): BORTEZOMIB
- Strength: 3.5MG/3.5ML/VIAL, 3.5MG/1.4ML/VIAL
- Dosage Form(s) / Route(s): Injectable;Intravenous, Subcutaneous
- Company: Maia Pharms Inc
- Approval Date: 27 July 2022
- 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: 27 July 2022 (PDF)
- Active Ingredient(s): Testosterone Undecanoate
- Strength: 100MG, 150MG, 200MG
- Dosage Form(s) / Route(s): Capsule; Oral
- Company: Marius Pharmaceuticals, Llc
- Approval Date: 27 July 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone
- Approved Label: 27 July 2022 (PDF)