Most Read Articles
05 May 2019
Statins, when taken before cardiac arrest, improve 1-year survival outcomes, a recent study has found.
Tristan Manalac, 22 Nov 2018
Initial treatment with endovascular therapy results in better amputation-free survival in patients with critical limb ischaemia compared with open surgical bypass, according to a study presented at the American Heart Association Scientific Session 2018 (AHA 2018), held in Chicago, Illinois.
09 May 2019
Cognitive impairments and delirium are frequent postoperative occurrences in patients who undergo coronary artery bypass grafting (CABG) surgery, according to a new meta-analysis.
Tristan Manalac, 29 May 2019
Coronary artery disease is prevalent among patients who have undergone coronary angiography, according to a new Philippine study presented at the recently concluded 2019 Congress of the Asian Pacific Society of Cardiology (APSC 2019). However, the obtained rates remain lower than that in other Asian countries.

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
05 May 2019
Statins, when taken before cardiac arrest, improve 1-year survival outcomes, a recent study has found.
Tristan Manalac, 22 Nov 2018
Initial treatment with endovascular therapy results in better amputation-free survival in patients with critical limb ischaemia compared with open surgical bypass, according to a study presented at the American Heart Association Scientific Session 2018 (AHA 2018), held in Chicago, Illinois.
09 May 2019
Cognitive impairments and delirium are frequent postoperative occurrences in patients who undergo coronary artery bypass grafting (CABG) surgery, according to a new meta-analysis.
Tristan Manalac, 29 May 2019
Coronary artery disease is prevalent among patients who have undergone coronary angiography, according to a new Philippine study presented at the recently concluded 2019 Congress of the Asian Pacific Society of Cardiology (APSC 2019). However, the obtained rates remain lower than that in other Asian countries.