Most Read Articles
Pearl Toh, 13 Feb 2021
While pregnant mothers with COVID-19 can mount a robust antibody response against the virus, transfer of antibodies from mothers to child across the placenta is less efficient than expected, according to a study presented during the SMFM 2021 Meeting.

Original New Drug Application Approvals by US FDA (01 - 15 February 2021)

16 Feb 2021
New drug applications approved by US FDA as of 01-15 February 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.

POSIMIR
  • Active Ingredient(s): Bupivacaine
  • Strength: 132MG/ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Durect Corp
  • Approval Date: 01 Feb 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. 
  • Approved Label01 Feb 2021 (PDF)
TEPMETKO
  • Active Ingredient(s): Tepotinib Hydrochloride
  • Strength: 225MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: EMD Serono Inc
  • Approval Date: 03 Feb 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
  • Approved Label03 Feb 2021 (PDF)
UKONIQ
  • Active Ingredient(s): Umbralisib Tosylate
  • Strength: 200MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: TG Therapeutics Inc
  • Approval Date: 05 Feb 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with:
    • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
    • Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. 
  • Approved Label05 Feb 2021 (PDF)
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Most Read Articles
Pearl Toh, 13 Feb 2021
While pregnant mothers with COVID-19 can mount a robust antibody response against the virus, transfer of antibodies from mothers to child across the placenta is less efficient than expected, according to a study presented during the SMFM 2021 Meeting.