Original New Drug Application Approvals by US FDA (16-31 August 2021)
02 Sep 2021
New drug applications approved by US FDA as of 16-31 August 2021 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.
JEMPERLI
JEMPERLI
- Active Ingredient(s): Dostarlimab-gxly
- Strength: 500MG/10ML
- Dosage Form(s) / Route(s): Injectable; Injection
- Company: Glaxosmithkline LLC
- Approval Date: 17 August 2021
- Submission Classification: Not available
- Indication(s): Indicated for the treatment of adult patients with mismatch repair deficient
(dMMR) recurrent or advanced:
- endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or
- solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
- Approved Label: 17 August 2021 (PDF)
- Active Ingredient(s): Succinylcholine Chloride
- Strength: 100MG/5ML (20MG/ML)
- Dosage Form(s) / Route(s): Solution; Intramuscular, Intravenous
- Company: Hikma Pharms
- Approval Date: 20 August 2021
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated in adults and pediatric patients:
- as an adjunct to general anesthesia
- to facilitate tracheal intubation
- to provide skeletal muscle relaxation during surgery or mechanical ventilation
- Approved Label: 20 August 2021 (PDF)
- Active Ingredient(s): Difelikefalin Acetate
- Strength: 65MCG/1.3ML (50MCG/ML)
- Dosage Form(s) / Route(s): Solution; Intravenous
- Company: Cara Therapeutics Inc
- Approval Date: 23 August 2021
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
- Approved Label: 23 August 2021 (PDF)
- Active Ingredient(s): Cyclophosphamide
- Strength: 500MG/2.5ml (200MG/ML); 1GM/5ML (200MG/ML)
- Dosage Form(s) / Route(s): Solution; Intravenous
- Company: Auromedics Pharma
- Approval Date: 25 August 2021
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Not available
- Approved Label: Not available
- Active Ingredient(s): Lonapegsomatropin-tcgd
- Strength: 3MG; 3.6MG; 4.3MG; 5.2MG; 6.3MG; 7.6MG; 9.1MG; 11MG; 13.3MG
- Dosage Form(s) / Route(s): Injectable; Injection
- Company: Acendis Pharma Endocrinology Div A/S
- Approval Date: 25 August 2021
- Submission Classification: Not available
- Indication(s): Indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)
- Approved Label: 25 August 2021 (PDF)
- Active Ingredient(s): Vancomycin
- Strength: 5G/100ML
- Dosage Form(s) / Route(s): Solution; Intravenous
- Company: Xellia Pharms Aps
- Approval Date: 26 August 2021
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Not available
- Approved Label: Not available
- Active Ingredient(s): Lorazepam
- Strength:1MG; 2MG; 3MG
- Dosage Form(s) / Route(s): Capsule, Extended Release; Oral
- Company: Almatica Pharma, LLC
- Approval Date: 27 August 2021
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Not available
- Approved Label: Not available