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

17 Nov 2021
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