Most Read Articles
04 Oct 2020
Obesity does not appear to be strongly correlated with an increased risk for febrile neutropaenia during levofloxacin prophylaxis in patients with haematological malignancies receiving intermediate-risk myelosuppressive chemotherapy, suggests a study.
Roshini Claire Anthony, 3 days ago

Initiation or switch to the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) led to low HIV-1 RNA viral load in people living with HIV (PLHIV), according to the BICSTaR study presented at HIV Glasgow 2020.

09 Nov 2020
Use of corticosteroids appears to be an effective treatment for paediatric drug reaction with eosinophilia and systemic symptoms (DRESS), suggest the results of a recent study. In severe cases, corticosteroids used in conjunction with intravenous immunoglobulin result in fast clinical improvement.
07 Aug 2020
Concomitant treatment with a nonsteroidal anti-inflammatory drug (NSAID) following myocardial infarction (MI) is associated with a higher risk of cardiovascular and bleeding events, a study has shown.

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
04 Oct 2020
Obesity does not appear to be strongly correlated with an increased risk for febrile neutropaenia during levofloxacin prophylaxis in patients with haematological malignancies receiving intermediate-risk myelosuppressive chemotherapy, suggests a study.
Roshini Claire Anthony, 3 days ago

Initiation or switch to the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) led to low HIV-1 RNA viral load in people living with HIV (PLHIV), according to the BICSTaR study presented at HIV Glasgow 2020.

09 Nov 2020
Use of corticosteroids appears to be an effective treatment for paediatric drug reaction with eosinophilia and systemic symptoms (DRESS), suggest the results of a recent study. In severe cases, corticosteroids used in conjunction with intravenous immunoglobulin result in fast clinical improvement.
07 Aug 2020
Concomitant treatment with a nonsteroidal anti-inflammatory drug (NSAID) following myocardial infarction (MI) is associated with a higher risk of cardiovascular and bleeding events, a study has shown.