Most Read Articles
6 days ago
The use of capsule endoscopy (CE) appears to be effective in the diagnosis of iron deficiency anaemia (IDA), yielding a 33.9-percent yield in this study, with 65.8 percent of patients undergoing further workup and 12.7 percent requiring therapeutic intervention.
Roshini Claire Anthony, Yesterday

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.

3 days ago
Eating behaviours have been shown to moderate the relationship between cumulated risk factors in the first 1,000 days and adiposity outcomes at 6 years of age, which underscores modifiable behavioural targets for interventions, reports a study.
Stephen Padilla, 2 days ago
Use of noninvasive ventilation (NIV), similar to invasive mechanical ventilation (IMV), appears to lessen mortality but may increase the risk for transmission of the novel coronavirus disease (COVID-19) in healthcare workers, suggest the results of a study.

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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Editor's Recommendations
Most Read Articles
6 days ago
The use of capsule endoscopy (CE) appears to be effective in the diagnosis of iron deficiency anaemia (IDA), yielding a 33.9-percent yield in this study, with 65.8 percent of patients undergoing further workup and 12.7 percent requiring therapeutic intervention.
Roshini Claire Anthony, Yesterday

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.

3 days ago
Eating behaviours have been shown to moderate the relationship between cumulated risk factors in the first 1,000 days and adiposity outcomes at 6 years of age, which underscores modifiable behavioural targets for interventions, reports a study.
Stephen Padilla, 2 days ago
Use of noninvasive ventilation (NIV), similar to invasive mechanical ventilation (IMV), appears to lessen mortality but may increase the risk for transmission of the novel coronavirus disease (COVID-19) in healthcare workers, suggest the results of a study.