Most Read Articles
Roshini Claire Anthony, 6 days ago

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
11 Sep 2019
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
Pearl Toh, 18 hours ago
The use of SGLT-2* inhibitors was not associated with a higher risk of severe or nonsevere urinary tract infections (UTIs) in patients with type 2 diabetes (T2D) compared with DPP**-4 inhibitors or GLP-1*** receptor agonists, a population-based cohort study shows.

Original New Drug Application Approvals by US FDA (1 - 15 November 2016)

15 Nov 2016
New drug applications approved by US FDA as of 1 - 15 November 2016 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.

SELZENTRY
  • Active Ingredient(s): MARAVIROC
  • Strength: 20MG/ML
  • Dosage Form: Oral Solution
  • Company: Viiv Hlthcare
  • Approval Date: November 4, 2016
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg
  • Approved Label: 11/04/2016 (PDF)

BONJESTA
  • Active Ingredient(s): DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
  • Strength: 20MG;20MG
  • Dosage Form: Extended-release oral tablet
  • Company: Duchesnay
  • Approval Date: November 7, 2016
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
  • Approved Label: 11/07/2016 (PDF)

VEMLIDY
  • Active Ingredient(s): TENOFOVIR ALAFENAMIDE
  • Strength: 25MG
  • Dosage Form: Oral tablet
  • Company: Gilead Sciences Inc
  • Approval Date: November 10, 2016
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease
  • Approved Label: 11/10/2016 (PDF)
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Most Read Articles
Roshini Claire Anthony, 6 days ago

Beta-blockers could reduce mortality risk in patients with heart failure with reduced ejection fraction (HFrEF) and moderate or moderately-severe renal dysfunction without causing harm, according to the BB-META-HF* trial presented at ESC 2019.

Prof. Vincent Wong, Prof. Ray Kim, Dr. Tan Poh Seng, 10 Sep 2019
Chronic hepatitis B (CHB) remains a major public health concern because of its worldwide distribution and potential adverse sequelae, including cirrhosis and hepatocellular carcinoma (HCC). At a recent symposium held during the GIHep Singapore 2019, Professor Vincent Wong from the Chinese University of Hong Kong and Professor Ray Kim from the Stanford University School of Medicine, Stanford, California, US, discussed antiviral treatments for CHB, with a focus on the novel agent tenofovir alafenamide (Vemlidy®). Dr Tan Poh Seng from the National University Hospital, Singapore, chaired the symposium.
11 Sep 2019
Blood pressure (BP) in children is influenced by early-life exposure to several chemicals, built environment and meteorological factors, suggests a study.
Pearl Toh, 18 hours ago
The use of SGLT-2* inhibitors was not associated with a higher risk of severe or nonsevere urinary tract infections (UTIs) in patients with type 2 diabetes (T2D) compared with DPP**-4 inhibitors or GLP-1*** receptor agonists, a population-based cohort study shows.