Original New Drug Application Approvals by US FDA (16 - 30 April 2021)
04 May 2021
New drug applications approved by US FDA as of 16-30 April 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
- Approval Date: 22 April 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.
- Approved Label: 22 April 2021 (PDF)
- Active Ingredient(s): Loncastuximab Tesirine-lpyl
- Strength: 10MG
- Dosage Form(s) / Route(s): Injectable; Injection
- Company: ADC Therapeutics SA
- Approval Date: 23 April 2021
- Submission Classification: Not available
- Indication(s): Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.
- Approved Label: 23 April 2021 (PDF)
- Active Ingredient(s): Naloxone Hydrochloride
- Strength: 8MG
- Dosage Form(s) / Route(s): Spray; Nasal
- Company: Hikma Pharms
- Approval Date: 29 April 2021
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
- Approved Label: 29 April 2021 (PDF)