Most Read Articles
Stephen Padilla, 23 May 2019
A recent study has shown an association between regular use of glucosamine supplement to relieve osteoarthritis pain and lower risk of cardiovascular disease (CVD) events.
Stephen Padilla, 11 Feb 2020
The inclusion of two proanthocyanidin (PA)-rich apples into normal diets improves cardiovascular disease (CVD) risk factors by reducing total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and intercellular cell adhesion molecule-1 (ICAM-1), as well as increasing microvascular vasodilation, in individuals with mildly elevated serum cholesterol concentrations, a recent study has shown.
Roshini Claire Anthony, 21 Dec 2019

In acutely ill medical patients, asymptomatic proximal deep-vein thrombosis (ASxDVT), as assessed via compression ultrasonography, is associated with an elevated risk of all-cause mortality, according to a post hoc analysis of the MAGELLAN* trial presented at ASH 2019.

Tristan Manalac, 14 Dec 2019
Luspatercept promotes red blood cell (RBC) transfusion independence among low-risk myelodysplastic syndrome (MDS) patients, according to a longer-term analysis of the MEDALIST study presented at the recently concluded 61st Annual Meeting and Exposition of the American Society of Hematology (ASH 2019).

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
Stephen Padilla, 23 May 2019
A recent study has shown an association between regular use of glucosamine supplement to relieve osteoarthritis pain and lower risk of cardiovascular disease (CVD) events.
Stephen Padilla, 11 Feb 2020
The inclusion of two proanthocyanidin (PA)-rich apples into normal diets improves cardiovascular disease (CVD) risk factors by reducing total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and intercellular cell adhesion molecule-1 (ICAM-1), as well as increasing microvascular vasodilation, in individuals with mildly elevated serum cholesterol concentrations, a recent study has shown.
Roshini Claire Anthony, 21 Dec 2019

In acutely ill medical patients, asymptomatic proximal deep-vein thrombosis (ASxDVT), as assessed via compression ultrasonography, is associated with an elevated risk of all-cause mortality, according to a post hoc analysis of the MAGELLAN* trial presented at ASH 2019.

Tristan Manalac, 14 Dec 2019
Luspatercept promotes red blood cell (RBC) transfusion independence among low-risk myelodysplastic syndrome (MDS) patients, according to a longer-term analysis of the MEDALIST study presented at the recently concluded 61st Annual Meeting and Exposition of the American Society of Hematology (ASH 2019).