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Original New Drug Application Approvals by US FDA (01 - 15 May 2018)

16 May 2018

New drug applications approved by US FDA as of 01 - 15 May 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.

PLENVU

  • Active Ingredient(s): polyethylene glycol (PEG) 3350; sodium ascorbate; sodium sulfate; ascorbic acid; sodium chloride; potassium chloride
  • Strength: 140G; 48.11G; 9G; 7.54G; 5.2G; 2.2G
  • Dosage Form: Solution
  • Company: Salix Pharms Inc.
  • Approval Date: 04 May 2018
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
  • Approved Label04/05/2018 (PDF)
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): Lamivudine; Tenofovir disoproxil fumarate
  • Strength: 300MG; 300MG
  • Dosage Form: Tablet
  • Company: Aurobindo Pharma Ltd.
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
  • Approved Label: 15/05/2018 (PDF)
RETACRIT
  • Active Ingredient(s): Epoetin alfa-epbx
  • Strength: 2,000 UNITS/ML;  3,000 UNITS/ML;  4,000 UNITS/ML;  10,000 UNITS/ML;  40,000 UNITS/ML
  • Dosage Form: Injectable
  • Company: Hospira Inc.
  • Approval Date: 15 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Treatment of anemia due to
      • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
      • Zidovudine in patients with HIV-infection
      • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
    • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
  • Approved Label: 15/05/2018 (PDF)
BENDAMUSTINE HYDROCHLORIDE
  • Active Ingredient(s): Bendamustine hydrochloride
  • Strength: 100 MG
  • Dosage Form: Injectable
  • Company: Eagle Pharms
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Indicated for treatment of patients with:
    • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established
    • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
  • Approved Label28/05/2018 (PDF)
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