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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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Most Read Articles
5 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
3 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 4 days ago
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, Yesterday
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.