Original New Drug Application Approvals by US FDA (16 - 30 November 2019)

04 Dec 2019
Original New Drug Application Approvals by US FDA (16 - 30 November 2019)
New drug applications approved by US FDA as of 16 - 30 November 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.

GIVLAARI
  • Active Ingredient(s): Givosiran sodium
  • Strength: 189 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Alnylam Pharms, Inc.
  • Approval Date: 20 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with acute hepatic porphyria (AHP).
  • Approved Label: 20 November 2019 (PDF)

XCOPRI
  • Active Ingredient(s): Cenobamate
  • Strength: 12.5 mg; 25 mg; 50 mg; 100 mg; 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: SK Life Science, Inc.
  • Approval Date: 21 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of partial-onset seizures in adult patients.
  • Approved Label: 21 November 2019 (PDF)

EXSERVAN
  • Active Ingredient(s): Riluzole
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Film; oral
  • Company: Aquestive Therap
  • Approval Date: 22 November 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS).
  • Approved Label: 22 November 2019 (PDF)

OXBRYTA
  • Active Ingredient(s): Voxelotor
  • Strength: 500 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Global Blood Therapeutics, Inc.
  • Approval Date: 25 November 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older.
  • Approved Label: 25 November 2019 (PDF)

POTASSIUM PHOSPHATES
  • Active Ingredient(s): Potassium phosphates
  • Strength: 3 mmol/mL; 4.4 mEq/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Fresenius Kabi USA
  • Approval Date: 26 November 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a source of phosphorus:
    • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated.
    • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
  • Approved Label: 26 November 2019 (PDF)

REDITREX (METHOTREXATE) INJECTION
  • Active Ingredient(s): Methotrexate
  • Strength: 7.5 mg; 10 mg; 12.5 mg; 15 mg; 17.5 mg; 20 mg; 22.5 mg; 25 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Cumberland Pharms
  • Approval Date: 27 November 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the:
    • Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
    • Symptomatic control of sever, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
  • Approved Label: 27 November 2019 (PDF)