Most Read Articles
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
Yesterday
Better sleep appears to weaken pain and fatigue in older, community-dwelling adults with hip or knee osteoarthritis (OA), reports a recent study.
5 days ago
Maribavir 400 mg twice daily appears to have comparable efficacy to valganciclovir at clearing cytomegalovirus viraemia in transplant recipients, a study has found.
4 days ago
Individuals with and without gout appear to have a similar risk of developing colorectal cancer, suggesting that gout does not contribute to a risk increase, a study has found.

Original New Drug Application Approvals by US FDA (16 - 31 January 2019)

31 Jan 2019
New drug applications approved by US FDA as of 16 - 31 January 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.

ONTRUZANT
  • Active Ingredient(s): Trastuzumab-dttb
  • Strength: 150 MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Samsung Bioepis Co Ltd
  • Approval Date: 18 Jan 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 Label: 18 Jan 2019 (PDF)
TOSYMRA
  • Active Ingredient(s): Sumatriptan
  • Strength: 10 MG
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Dr Reddy's Labs Ltd
  • Approval Date: 25 Jan 2019
  • Submission Classification:  Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label: 25 Jan 2019 (PDF)
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Editor's Recommendations
Most Read Articles
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
Yesterday
Better sleep appears to weaken pain and fatigue in older, community-dwelling adults with hip or knee osteoarthritis (OA), reports a recent study.
5 days ago
Maribavir 400 mg twice daily appears to have comparable efficacy to valganciclovir at clearing cytomegalovirus viraemia in transplant recipients, a study has found.
4 days ago
Individuals with and without gout appear to have a similar risk of developing colorectal cancer, suggesting that gout does not contribute to a risk increase, a study has found.