Original New Drug Application Approvals by US FDA (01-15 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 Label: 02 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 Label: 03 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 Label: 03 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 Label: 06 May 2019 (PDF)