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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
Yesterday
No association exists between physical activity and the risk of urological cancer, according to a population-based prospective study in Japan.
6 days ago
Olanzapine confers a modest therapeutic effect on weight compared with placebo in adult outpatients with anorexia nervosa, a study has shown. However, it does not appear to offer significant benefit for psychological symptoms.
2 days ago
Patients with childhood-onset inflammatory bowel disease are more likely to die than the general population, a study suggests.
2 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.