Most Read Articles
5 days ago
No association exists between physical activity and the risk of urological cancer, according to a population-based prospective study in Japan.
6 days ago
Patients with childhood-onset inflammatory bowel disease are more likely to die than the general population, a study suggests.
6 days ago
Reduced caloric intake results in a significant improvement in glucose metabolism and body-fat composition, including liver-fat content, according to a study. Changes in ferritin levels appear to mediate the striking reduction in liver fat.
Pearl Toh, 15 Feb 2019
A latest study at ISC 2019 shows that even patients with large-core stroke damage can have a good outcome after mechanical clot removal with endovascular thrombectomy (EVT), depending on the size of the infarct and time lapses between stroke onset and treatment.

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
5 days ago
No association exists between physical activity and the risk of urological cancer, according to a population-based prospective study in Japan.
6 days ago
Patients with childhood-onset inflammatory bowel disease are more likely to die than the general population, a study suggests.
6 days ago
Reduced caloric intake results in a significant improvement in glucose metabolism and body-fat composition, including liver-fat content, according to a study. Changes in ferritin levels appear to mediate the striking reduction in liver fat.
Pearl Toh, 15 Feb 2019
A latest study at ISC 2019 shows that even patients with large-core stroke damage can have a good outcome after mechanical clot removal with endovascular thrombectomy (EVT), depending on the size of the infarct and time lapses between stroke onset and treatment.