Most Read Articles
Natalia Reoutova, 16 Aug 2019
A recently published study involving 4,517 individuals confirmed the role of BRCA2 mutations in genetic predisposition to oesophageal squamous cell carcinoma (OSCC) among Chinese.

Original New Drug Application Approvals by US FDA (01 - 15 June 2019)

15 Jun 2019
New drug applications approved by US FDA as of 01 - 15 June 2019 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.

NUCALA
  • Active Ingredient(s): Mepolizumab
  • Strength: 100 mg/mL
  • Dosage Form(s) / Route(s): Injectable; subcutaneous
  • Company: GlaxoSmithKline
  • Approval Date: 06 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
    • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 
  • Approved Label06 June 2019 (PDF)

POLIVY
  • Active Ingredient(s): Polatuzumab vedotin-piiq
  • Strength: 140 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Genentech
  • Approval Date: 10 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. 
  • Approved Label10 June 2019 (PDF)

KANJINTI
  • Active Ingredient(s): Trastuzumab-anns
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Amgen, Inc.
  • Approval Date: 13 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • The treatment of HER2 overexpressing breast cancer.
    • The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label13 June 2019 (PDF)
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Most Read Articles
Natalia Reoutova, 16 Aug 2019
A recently published study involving 4,517 individuals confirmed the role of BRCA2 mutations in genetic predisposition to oesophageal squamous cell carcinoma (OSCC) among Chinese.