Most Read Articles
07 Sep 2019
Eating mushrooms has no correlation with biomarkers and risks of cardiovascular disease (CVD) and type 2 diabetes (T2D) in adults, a US study has shown.
03 Sep 2019
Sleep apnoea is highly prevalent but largely undetected in the general population of middle-aged adults, with a symptom-based strategy proving to be useless for specific diagnosis, according to a recent study. Moreover, mild sleep apnoea represents a higher-risk phenotype with manifestly increased metabolic, inflammatory and cardiovascular risk factor burden, with potential public health implications.
Rachel Soon, 2 days ago

Adding simvastatin as an adjuvant to standard triple therapy in Helicobacter pylori treatment may help compensate for increasing antimicrobial resistance, according to a new study.

Christina Lau, 03 Sep 2019
The sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of death and hospitalization in patients with heart failure (HF) with reduced ejection fraction (rEF) regardless of whether they have type 2 diabetes mellitus (T2DM), the DAPA-HF trial has shown.

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

15 May 2019
New drug applications approved by US FDA as of 01 - 15 May 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.

QTERNMET XR
  • Active Ingredient(s): Dapagliflozin; Saxagliptin; Metformin hydrochloride
  • Strength: 2.5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HCl; 5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HCl; 5 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HCl; 10 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HCl 
  • Dosage Form(s) / Route(s): Extended release tablet; oral
  • Company: AstraZeneca AB
  • Approval Date: 02 May 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s)
    • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
    • QTERNMET XR initiation is intended only for patients currently taking metformin.
  • Approved Label02 May 2019 (PDF)

VYNDAQEL
  • Active Ingredient(s): Tafamidis meglumine
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: FoldRx Pharmaceuticals, Inc.
  • Approval Date: 03 May 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
  • Approved Label03 May 2019 (PDF)

VYNDAMAX
  • Active Ingredient(s): Tafamidis
  • Strength: 61 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: FoldRx Pharmaceuticals, Inc.
  • Approval Date: 03 May 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. 
  • Approved Label03 May 2019 (PDF)

RUZURGI
  • Active Ingredient(s): Amifampridine
  • Strength: 10 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Jacobus Pharmaceuticals Company, Inc.
  • Approval Date: 06 May 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patient 6 to less than 17 years of age. 
  • Approved Label06 May 2019 (PDF)
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Most Read Articles
07 Sep 2019
Eating mushrooms has no correlation with biomarkers and risks of cardiovascular disease (CVD) and type 2 diabetes (T2D) in adults, a US study has shown.
03 Sep 2019
Sleep apnoea is highly prevalent but largely undetected in the general population of middle-aged adults, with a symptom-based strategy proving to be useless for specific diagnosis, according to a recent study. Moreover, mild sleep apnoea represents a higher-risk phenotype with manifestly increased metabolic, inflammatory and cardiovascular risk factor burden, with potential public health implications.
Rachel Soon, 2 days ago

Adding simvastatin as an adjuvant to standard triple therapy in Helicobacter pylori treatment may help compensate for increasing antimicrobial resistance, according to a new study.

Christina Lau, 03 Sep 2019
The sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of death and hospitalization in patients with heart failure (HF) with reduced ejection fraction (rEF) regardless of whether they have type 2 diabetes mellitus (T2DM), the DAPA-HF trial has shown.