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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
3 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
2 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Tristan Manalac, 6 days ago
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).