Most Read Articles
Pearl Toh, 10 Oct 2019
Adding a LAMA* to the double combination therapy of ICS** plus LABA*** in a single inhaler improves lung function and reduces exacerbations in patients whose asthma is inadequately controlled with the combination treatment, according to the TRIMARAN and TRIGGER# studies presented at ERS 2019.
2 days ago
Environmental quality and exposure to pollution may play a small part in the development of metabolic diseases, such as diabetes, a new study has found.
Tristan Manalac, 4 days ago
Sleep deprivation impairs adolescents’ long-term retention of classroom material, according to a recent Singapore study.
6 days ago
Eating alone may help in weight management as findings of a recent study suggest that eating with friends lead to higher food intake.

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
Pearl Toh, 10 Oct 2019
Adding a LAMA* to the double combination therapy of ICS** plus LABA*** in a single inhaler improves lung function and reduces exacerbations in patients whose asthma is inadequately controlled with the combination treatment, according to the TRIMARAN and TRIGGER# studies presented at ERS 2019.
2 days ago
Environmental quality and exposure to pollution may play a small part in the development of metabolic diseases, such as diabetes, a new study has found.
Tristan Manalac, 4 days ago
Sleep deprivation impairs adolescents’ long-term retention of classroom material, according to a recent Singapore study.
6 days ago
Eating alone may help in weight management as findings of a recent study suggest that eating with friends lead to higher food intake.