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)