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10 Apr 2019
Leafy green and root vegetables containing large amounts of nitrate confer substantial defence against salt-induced increases in blood pressure, especially in the context of nonrestricted salt intake, a study has shown.
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17 Jul 2018
Higher total intake of dairy products, especially yogurt, may help reduce the risk of incident hypertension in middle-aged and older adult men and women, suggests a recent study.
19 Oct 2016
A new system called Preoperative Evaluation Clinic (PEC) workflow for cardiothoracic surgery significantly reduced the cancellation rate of elective cases at the National Heart Centre Singapore (NHCS), according to a study presented at the ASEAN Federation of Cardiology Congress (AFCC) 2016 in Yangon, Myanmar.

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

5 days ago
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
10 Apr 2019
Leafy green and root vegetables containing large amounts of nitrate confer substantial defence against salt-induced increases in blood pressure, especially in the context of nonrestricted salt intake, a study has shown.
12 May 2019
Regular consumption of chili pepper is associated with reduced risk of total and cardiovascular death regardless of adherence to Mediterranean diet, according to a study from Italy.
17 Jul 2018
Higher total intake of dairy products, especially yogurt, may help reduce the risk of incident hypertension in middle-aged and older adult men and women, suggests a recent study.
19 Oct 2016
A new system called Preoperative Evaluation Clinic (PEC) workflow for cardiothoracic surgery significantly reduced the cancellation rate of elective cases at the National Heart Centre Singapore (NHCS), according to a study presented at the ASEAN Federation of Cardiology Congress (AFCC) 2016 in Yangon, Myanmar.