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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
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.
3 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, 18 Nov 2020
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).