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Most Read Articles
Cardiac biomarkers pinpoint CAP patients at high risk of adverse CV events
4 days ago
Cardiac biomarkers are useful for identifying community-acquired pneumonia (CAP) patients with an elevated risk of early and long-term cardiovascular (CV) events, according to a study.
Tofogliflozin safe, effective for seniors with T2DM
2 days ago
Tofogliflozin is safe and effective for elderly patients with type 2 diabetes mellitus (T2DM), regardless of insulin and oral antidiabetic drugs, reports a new Japan study.
Poor lung function may predict future arterial stiffness
17 Aug 2019
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.
Systolic blood pressure factors in subarachnoid haemorrhage but not in intracranial aneurysm
6 days ago
Systolic blood pressure appears to have a strong association with aneurysmal subarachnoid haemorrhage (aSAH) but not with unruptured intracranial aneurysm (UIA), whereas current smoking and female sex are risk factors for both conditions, 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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Most Read Articles
Cardiac biomarkers pinpoint CAP patients at high risk of adverse CV events
4 days ago
Cardiac biomarkers are useful for identifying community-acquired pneumonia (CAP) patients with an elevated risk of early and long-term cardiovascular (CV) events, according to a study.
Tofogliflozin safe, effective for seniors with T2DM
2 days ago
Tofogliflozin is safe and effective for elderly patients with type 2 diabetes mellitus (T2DM), regardless of insulin and oral antidiabetic drugs, reports a new Japan study.
Poor lung function may predict future arterial stiffness
17 Aug 2019
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.
Systolic blood pressure factors in subarachnoid haemorrhage but not in intracranial aneurysm
6 days ago
Systolic blood pressure appears to have a strong association with aneurysmal subarachnoid haemorrhage (aSAH) but not with unruptured intracranial aneurysm (UIA), whereas current smoking and female sex are risk factors for both conditions, a study has found.