Most Read Articles
Elvira Manzano, 3 days ago
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.
Stephen Padilla, 15 Mar 2018
The use of paediatric epidural analgesia has been declining over the years and is slowly being replaced by other analgesic modalities with superior safety profiles, according to a Singapore study.

Original New Drug Application Approvals by US FDA (16 - 30 April 2021)

5 days ago
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)
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Most Read Articles
Elvira Manzano, 3 days ago
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.
Stephen Padilla, 15 Mar 2018
The use of paediatric epidural analgesia has been declining over the years and is slowly being replaced by other analgesic modalities with superior safety profiles, according to a Singapore study.