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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
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 5 days ago
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
6 days ago
Testosterone treatment may slightly improve sexual functioning and quality of life in men without underlying organic causes of hypogonadism, but it offers little to no benefit for other common symptoms of ageing, according to a study. In addition, long-term efficacy and safety of this therapy remain unknown.