Most Read Articles
Stephen Padilla, 21 Jul 2017
Adherence to a beneficial lifestyle may significantly reduce the risk of chronic hypertension after hypertensive disorders of pregnancy (HDP) such as gestational hypertension and pre-eclampsia, a recent study suggests. Keeping a healthy weight appears to be critical in women with a history of HDP compared with those without such a history.
Natalia Reoutova, 6 days ago

MitraClip NTR and XTR systems are effective and well tolerated for primary mitral regurgitation (MR), as shown in the prospective, multicentre, single-arm, international, post-marketing, real-world, observational EXPAND study presented at the American College of Cardiology 2020/World Congress of Cardiology (ACC.20/WCC) virtual meeting.

Pearl Toh, 4 days ago
Taking ticagrelor alone — and dropping aspirin — after 3 months of DAPT* post-PCI** significantly reduced bleeding events without increasing the risk of ischaemic adverse events compared with continuing a DAPT of ticagrelor plus aspirin, the TICO*** trial has shown.
09 Jul 2017
The Dietary Approaches to Stop Hypertension (DASH) diet is effective in reducing uric acid concentrations and risks of gout in males, a new prospective cohort study reveals. In contrast, Western diets up the risk of gout.

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, 21 Jul 2017
Adherence to a beneficial lifestyle may significantly reduce the risk of chronic hypertension after hypertensive disorders of pregnancy (HDP) such as gestational hypertension and pre-eclampsia, a recent study suggests. Keeping a healthy weight appears to be critical in women with a history of HDP compared with those without such a history.
Natalia Reoutova, 6 days ago

MitraClip NTR and XTR systems are effective and well tolerated for primary mitral regurgitation (MR), as shown in the prospective, multicentre, single-arm, international, post-marketing, real-world, observational EXPAND study presented at the American College of Cardiology 2020/World Congress of Cardiology (ACC.20/WCC) virtual meeting.

Pearl Toh, 4 days ago
Taking ticagrelor alone — and dropping aspirin — after 3 months of DAPT* post-PCI** significantly reduced bleeding events without increasing the risk of ischaemic adverse events compared with continuing a DAPT of ticagrelor plus aspirin, the TICO*** trial has shown.
09 Jul 2017
The Dietary Approaches to Stop Hypertension (DASH) diet is effective in reducing uric acid concentrations and risks of gout in males, a new prospective cohort study reveals. In contrast, Western diets up the risk of gout.