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

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