Original New Drug Application Approvals by US FDA (16 - 30 June 2022)

30 Jun 2022
Original New Drug Application Approvals by US FDA (16 - 30 June 2022)
New drug applications approved by US FDA as of 16 - 30 June 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.

SKYRIZI
  • Active Ingredient(s): Risankizumab-Rzaa
  • Strength: 600MG/VIAL
  • Dosage Form(s) / Route(s): Injectable;Intravenous
  • Company: Abbvie Inc
  • Approval Date: 16 June 2022
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
    • Active psoriatic arthritis in adults.
    • Moderately to severely active Crohn's disease in adults.
  • Approved Label:  16 June 2022 (PDF)
PHEBURANE
  • Active Ingredient(s): Sodium Phenylbutyrate
  • Strength: 84GM/BOT
  • Dosage Form(s) / Route(s): Pellets;Oral
  • Company: Medunik
  • Approval Date: 17 June 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).
  • Approved Label:  17 June 2022 (PDF)
RELEXXII
  • Active Ingredient(s): Methylphenidate Hydrochloride
  • Strength: 18MG, 27MG, 36MG, 45MG, 54MG, 63MG, 72MG
  • Dosage Form(s) / Route(s): Tablet, Extended Release;Oral
  • Company: Osmotica Pharm Corp
  • Approval Date: 23 June 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older
  • Approved Label:  23 June 2022 (PDF)
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