Most Read Articles
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
12 Dec 2016

Associate Professor Ng Lee Ching, Director of the Environmental Health Institute (EHI) at the National Environment Agency (NEA), Singapore, speaks about the role of primary care physicians and government agencies in preventing dengue epidemics.

22 Aug 2018
In patients with atrial fibrillation (AF) naïve to oral anticoagulants (OACs), standard-dose nonvitamin K antagonist OACs (NOACs) provides better survival benefits than warfarin, a recent meta-analysis has shown.
Stephen Padilla, 31 Aug 2018
Treatment with rivaroxaban results in less recurrent venous thromboembolism (VTE) in frail patients with VTE, with similar good bleeding outcomes, compared with warfarin, reports a study.

Original New Drug Application Approvals by US FDA (01 - 15 September 2019)

17 Sep 2019
New drug application approved by US FDA as of 01 - 15 September 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.

GVOKE
  • Active Ingredient(s): Glucagon
  • Strength: 0.5 mg; 1 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Xeris Pharma, Inc.
  • Approval Date: 10 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
  • Approved Label10 September 2019 (PDF)

IBSRELA
  • Active Ingredient(s): Tenapanor
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Ardelyx, Inc.
  • Approval Date: 12 September 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
  • Approved Label12 September 2019 (PDF)
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Editor's Recommendations
Most Read Articles
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
12 Dec 2016

Associate Professor Ng Lee Ching, Director of the Environmental Health Institute (EHI) at the National Environment Agency (NEA), Singapore, speaks about the role of primary care physicians and government agencies in preventing dengue epidemics.

22 Aug 2018
In patients with atrial fibrillation (AF) naïve to oral anticoagulants (OACs), standard-dose nonvitamin K antagonist OACs (NOACs) provides better survival benefits than warfarin, a recent meta-analysis has shown.
Stephen Padilla, 31 Aug 2018
Treatment with rivaroxaban results in less recurrent venous thromboembolism (VTE) in frail patients with VTE, with similar good bleeding outcomes, compared with warfarin, reports a study.