Original New Drug Application Approvals by US FDA (16 - 31 October 2020)

04 Nov 2020
New drug applications approved by US FDA as of 16 - 31 October 2020 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.

EPHEDRINE SULFATE
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 5 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nevakar, Inc.
  • Approval Date: 16 October 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available

ESOMEPRAZOLE
  • Active Ingredient(s): Esomeprazole
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet, orally disintegrating, delayed release; oral
  • Company: Dexcel Pharma Technologies Ltd.
  • Approval Date: 20 October 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available

VEKLURY
  • Active Ingredient(s): Remdesivir
  • Strength: 5 mg/mL; 100 mg/vial
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Gilead Sciences, Inc.
  • Approval Date: 22 October 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for adults and pediatric patients (12 years of age and older weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. 
  • Approved Label22 October 2020 (PDF)

EYSUVIS
  • Active Ingredient(s): Loteprednol etabonate
  • Strength: 0.25%
  • Dosage Form(s) / Route(s): Solution; ophthalmic
  • Company: Kala Pharms, Inc.
  • Approval Date: 26 October 2020
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. 
  • Approved Label26 October 2020 (PDF)

BRONCHITOL
  • Active Ingredient(s): Mannitol
  • Strength: 400 mg
  • Dosage Form(s) / Route(s): Powder; inhalation
  • Company: Chiesi USA, Inc.
  • Approval Date: 30 October 2020
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.
  • Approved Label30 October 2020 (PDF)
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