Original New Drug Application Approvals by US FDA (01 - 15 April 2022)

18 Apr 2022
Original New Drug Application Approvals by US FDA (01 - 15 April 2022)
New drug applications approved by US FDA as of 01-15 April 2022 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.

VIJOICE
  • Active Ingredient(s): Alpelisib
  • Strength: 50MG; 125MG; 200MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date: 05 April 2022
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CARelated Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)
  • Approved Label: 05 April 2022 (PDF)
IGALMI
  • Active Ingredient(s): Dexmedetomidine
  • Strength: 180MCG
  • Dosage Form(s) / Route(s): Film; Sublingual
  • Company: Bioxcel Therapeutics, Inc.
  • Approval Date: 05 April 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.
  • Approved Label: 05 April 2022 (PDF)
BENDAMUSTINE HYDROCHLORIDE
  • Active Ingredient(s): Bendamustine Hydrochloride
  • Strength: 25MG/ML
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Apotex Inc
  • Approval Date: 08 April 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
ALYMSYS
  • Active Ingredient(s): Bevacizumab-maly
  • Strength: 100MG/4ML(25MG/ML; 400MG/16ML(25MG/ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amneal Pharms LLC
  • Approval Date: 13 April 2022
  • Submission Classification: Not available
  • Indication(s): for the treatment of:
    • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
    • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Approved Label: 13 April 2022 (PDF)