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

04 Dec 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 Label20 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 Label21 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 Label22 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 Label25 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 Label26 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 Label27 November 2019 (PDF)
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Most Read Articles
Stephen Padilla, 06 Aug 2020
The novel coronavirus disease (COVID-19) pandemic appears to have a significant impact on oncological care, according to a study, which stresses the need for psycho-oncological support for cancer patients.
01 Aug 2020
Supplementation with probiotics may have positive effects in patients with type 2 diabetes mellitus (T2DM), reports a recent meta-analysis.
06 Aug 2020
Sodium–glucose cotransporter-2 (SGLT-2) inhibitors increase the risk for diabetic ketoacidosis (DKA) by almost threefold, with molecule-specific analyses suggesting a class effect, according to a study.
Stephen Padilla, 3 days ago
Pre-exposure prophylaxis (PrEP) containing either long-acting injectable cabotegravir (CAB) or tenofovir/emtricitabine (TDF/FTC) is safe and effective for transgender women (TGW) and cisgender men who have sex with men (MSM), but CAB results in a much lower HIV incidence compared to TDF/FTC, results of the HIV Prevention Trials Network (HPTN) 083 have shown.