Most Read Articles
21 Aug 2019
Daily use of the selective oral Bruton’s tyrosine kinase inhibitor evobrutinib in the treatment of patients with relapsing multiple sclerosis helps reduce the number of gadolinium-enhancing lesions, according to the results of a phase II trial.
20 Aug 2019
The combination of pravastatin and sorafenib does not appear to improve survival in patients with hepatocellular carcinoma (HCC), a recent study has shown.
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Roshini Claire Anthony, 20 Aug 2019

The combination of emtricitabine and dolutegravir with either a tenofovir alafenamide fumarate (TAF) or tenofovir disoproxil fumarate (TDF)-based regimen fared similarly to a TDF-emtricitabine-efavirenz regimen in reducing HIV-1 RNA levels, according to results of the phase III ADVANCE* study presented at IAS 2019.

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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Most Read Articles
21 Aug 2019
Daily use of the selective oral Bruton’s tyrosine kinase inhibitor evobrutinib in the treatment of patients with relapsing multiple sclerosis helps reduce the number of gadolinium-enhancing lesions, according to the results of a phase II trial.
20 Aug 2019
The combination of pravastatin and sorafenib does not appear to improve survival in patients with hepatocellular carcinoma (HCC), a recent study has shown.
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Roshini Claire Anthony, 20 Aug 2019

The combination of emtricitabine and dolutegravir with either a tenofovir alafenamide fumarate (TAF) or tenofovir disoproxil fumarate (TDF)-based regimen fared similarly to a TDF-emtricitabine-efavirenz regimen in reducing HIV-1 RNA levels, according to results of the phase III ADVANCE* study presented at IAS 2019.