Most Read Articles
Christina Lau, 02 Jan 2020

Tolvaptan improves dyspnoea, increases sodium levels and reduces body weight in patients with acute heart failure (HF) with or without hyponatraemia, but no significant effect is seen in mortality or rehospitalization, according to a recent meta-analysis.

Pearl Toh, 15 Apr 2020
Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis who are at low surgical risk appears to be safe with low rates of death or disabling stroke at 30 days, according to a study presented at the ACC.20/WCC Virtual Meeting.

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
Christina Lau, 02 Jan 2020

Tolvaptan improves dyspnoea, increases sodium levels and reduces body weight in patients with acute heart failure (HF) with or without hyponatraemia, but no significant effect is seen in mortality or rehospitalization, according to a recent meta-analysis.

Pearl Toh, 15 Apr 2020
Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis who are at low surgical risk appears to be safe with low rates of death or disabling stroke at 30 days, according to a study presented at the ACC.20/WCC Virtual Meeting.