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 Label: 22 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 Label: 26 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 Label: 30 October 2020 (PDF)