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Original New Drug Application Approvals by US FDA (16 - 31 January 2018)

31 Jan 2018

New drug applications approved by US FDA as of 16-31 January 2018 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.

CABAZITAXEL INJECTION

  • Active Ingredient(s): Cabazitaxel
  • Strength: 40mg/4ml, 60mg/6ml
  • Dosage Form: Injectable;injection
  • Company: Actavis LLC
  • Approval Date: January 17, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available

TIGECYCLINE
  • Active Ingredient(s): Tigecycline
  • Strength: 50 mg
  • Dosage Form: Injectable;injection
  • Company: Accord Hlthcare Inc
  • Approval Date: January 18, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated  in patients 18 years of age and older for:
    • Complicated skin and skin structure infections.
    • Complicated intra-abdominal infections.
    • Community-acquired bacterial pneumonia.
  • Approved Label: 01/18/2018(PDF)
LUTATHERA
  • Active Ingredient(s): Lutetium LU 177 Dotatate
  • Strength: 370 mbq/ml
  • Dosage Form: Injectable;injection
  • Company: Advanced Accelerator Applications USA Inc
  • Approval Date: January 26, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of somastatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • Approved Label: 01/26/2018(PDF)
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Most Read Articles
3 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.
Yesterday
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, 2 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.
3 days ago
Better sleep appears to weaken pain and fatigue in older, community-dwelling adults with hip or knee osteoarthritis (OA), reports a recent study.