Original New Drug Application Approvals by US FDA (16-28 February 2023)

28 Feb 2023
Original New Drug Application Approvals by US FDA (16-28 February 2023)
New drug applications approved by US FDA as of 16-28 February 2023 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.

LAMZEDE
  • Active Ingredient(s): Velmanase Alfa-tycv
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Powder, For Injection Solution, Lyophilized Powder
  • Company: Chiesi Farmaceutici Spa
  • Approval Date: 16 February 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients
  • Approved Label:  16 February (PDF)
AUSTEDO XR
  • Active Ingredient(s): Deutetrabenzine
  • Strength: 6MG; 12MG; 24MG
  • Dosage Form(s) / Route(s): Tablet, Extended Release; Oral
  • Company: Teva Neuroscience Inc
  • Approval Date: 17 February 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adults for the treatment of:
    • Chorea associated with Huntington’s disease
    • Tardive dyskinesia
  • Approved Label:  17 February (PDF)
FILSPARI
  • Active Ingredient(s): Sparsentan
  • Strength: 200MG; 400MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Travere
  • Approval Date: 17 February 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
    This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FILSPARI slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • Approved Label:  17 February (PDF)
SYFOVRE
  • Active Ingredient(s): Pegcetacoplan
  • Strength: 150MG/ML
  • Dosage Form(s) / Route(s): Injectable;intravitreal
  • Company: Apellis Pharms
  • Approval Date: 17 February 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
  • Approved Label:  17 February (PDF)
PREVDUO
  • Active Ingredient(s): Neostigmine Methylsulfate And Glycopyrrolate
  • Strength: 3MG/3ML 0.6MG/3ML
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Slayback Pharma Llc
  • Approval Date: 23 February 2023
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated in patients age two years and above for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.
  • Approved Label:  23 February (PDF)
SKYCLARYS
  • Active Ingredient(s): Omaveloxolone
  • Strength: 50MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Reata Pharms
  • Approval Date: 28 February 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
  • Approved Label:  28 February (PDF)