Original New Drug Application Approvals by US FDA (01-15 November 2021)

New drug applications approved by US FDA as of 01-15 November 2021 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.

DYANAVEL XR

• Active Ingredient(s): Amphetamine
• Strength: 5MG; 10MG; 15MG; 20MG
• Dosage Form(s) / Route(s): Tablet, Extended Release; Oral
• Company: Tris Pharma Inc
• Approval Date: 04 November 2021
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
• Approved Label: 04 November 2021 (PDF)

EPRONTIA

• Active Ingredient(s): Topiramate
• Strength: 25MG/ML
• Dosage Form(s) / Route(s): Solution; Oral
• Company: Azurity
• Approval Date: 05 November 2021
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for:
  • Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with LennoxGastaut syndrome in patients 2 years of age and older.
  • Preventive treatment of migraine in patients 12 years of age and older.
• Approved Label: 05 November 2021 (PDF)

DHIVY

• Active Ingredient(s): Carbidopa; Levodopa
• Strength: 25MG; 100MG
• Dosage Form(s) / Route(s): Tablet; Oral
• Company: Riverside Pharma Corp
• Approval Date: 12 November 2021
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
• Approved Label: 12 November 2021 (PDF)

BESREMI

• Active Ingredient(s): Ropeginterferon Alfa-2b-njft
• Strength: 500 MCG/ML
• Dosage Form(s) / Route(s): Injectable; Subcutaneous
• Company: Pharmaessentia Corp
• Approval Date: 12 November 2021
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of adults with polycythemia vera.
• Approved Label: 12 November 2021 (PDF)

BENDAMUSTINE HYDROCHLORIDE

• Active Ingredient(s): Bendamustine Hydrochloride
• Strength: 100MG/4ML (25MG/ML)
• Dosage Form(s) / Route(s): Solution; Intravenous
• Company: Dr Reddys Labs Ltd
• Approval Date: 12 November 2021
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s):Not available
• Approved Label: Not available