Most Read Articles
Elvira Manzano, 06 May 2021
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.

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
  • 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 Label22 April 2021 (PDF)
ZYNLONTA
  • 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 Label23 April 2021 (PDF)
KLOXXADO
  • 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 Label29 April 2021 (PDF)
Editor's Recommendations
Most Read Articles
Elvira Manzano, 06 May 2021
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.