Most Read Articles
5 days ago
Treatment with nebivolol yields more favourable changes in 24-hour, intradialytic and daytime systolic and diastolic blood pressure variability in patients with intradialytic hypertension, a study has found.
Stephen Padilla, 3 days ago
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
6 days ago
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
Yesterday
The known benefits of coffee drinking keep on growing as a new study suggests that coffee consumption can lower the risk of liver-related hospitalizations.

Original New Drug Application Approvals by US FDA (16 - 28 February 2019)

07 Mar 2019
New drug applications approved by US FDA as of 16 - 28 February 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.

LOTEMAX SM
  • Active Ingredient(s): Loteprednol etabonate
  • Strength: 0.38%
  • Dosage Form(s) / Route(s): Gel; Ophthalmic
  • Company: Bausch and Lomb Inc.
  • Approval Date: 22 Feb 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of postoperative inflammation and pain following ocular surgery.
  • Approved Label: 22 Feb 2019 (PDF)
ADHANSIA XR
  • Active Ingredient(s): Methylphenidate hydrochloride
  • Strength: 25 mg; 35 mg; 45 mg; 55 mg; 70 mg; 85 mg
  • Dosage Form(s) / Route(s): Capsule; Extended release
  • Company: Purdue Pharma L.P.
  • Approval Date: 27 Feb 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
  • Approved Label: 27 Feb 2019 (PDF)
HERCEPTIN HYLECTA
  • Active Ingredient(s): Trastuzumab; Hyaluronidase-oysk
  • Strength: 600 mg; 10000 units
  • Dosage Form(s) / Route(s): Injectable; Subcutaneous
  • Company: Genentech Inc.
  • Approval Date: 28 Feb 2019
  • Submission Classification:
  • Indication(s): Indicated in adults for the treatment of HER2-overexpressing breast cancer.
  • Approved Label: 28 Feb 2019 (PDF)
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Most Read Articles
5 days ago
Treatment with nebivolol yields more favourable changes in 24-hour, intradialytic and daytime systolic and diastolic blood pressure variability in patients with intradialytic hypertension, a study has found.
Stephen Padilla, 3 days ago
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
6 days ago
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
Yesterday
The known benefits of coffee drinking keep on growing as a new study suggests that coffee consumption can lower the risk of liver-related hospitalizations.