Most Read Articles
Pearl Toh, 22 Oct 2020
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
4 days ago
Weight suppression appears to result in future onset of eating disorders characterized by dietary restriction or compensatory weight control behaviours, suggesting weight-suppressed women represent an at-risk group that may benefit from selective prevention programmes, a study has found.
Pearl Toh, 3 days ago
Quadrivalent human papillomavirus (HPV) vaccination can substantially reduce the risk of invasive cervical cancer, by up to almost 90 percent in women who were vaccinated early, a large Swedish registry-based study has shown.

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
Pearl Toh, 22 Oct 2020
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
4 days ago
Weight suppression appears to result in future onset of eating disorders characterized by dietary restriction or compensatory weight control behaviours, suggesting weight-suppressed women represent an at-risk group that may benefit from selective prevention programmes, a study has found.
Pearl Toh, 3 days ago
Quadrivalent human papillomavirus (HPV) vaccination can substantially reduce the risk of invasive cervical cancer, by up to almost 90 percent in women who were vaccinated early, a large Swedish registry-based study has shown.