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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
5 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
6 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.
Pearl Toh, 4 days ago
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.
12 Apr 2019
Acetaminophen remains a safe choice of analgesic for most elderly residents of nursing homes, a recent study suggests.