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

16 Mar 2021
New drug applications approved by US FDA as of 01-15 March 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.

AZSTARYS
  • Active Ingredient(s): Serdexmethylphenidate; Dexmethylphenidate
  • Strength: 26.1MG/5.2MG; 39.2MG/7.8MG; 52.3MG/10.4MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Commcave Therapeutics SA
  • Approval Date: 02 Mar 2021
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s):  Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older
  • Approved Label:  02 Mar 2021 (PDF)
FOTIVDA
  • Active Ingredient(s): Tivozanib
  • Strength: 0.89MG; 1.34MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Aveo Pharmaceuticals Inc
  • Approval Date: 10 Mar 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):  Not Available
  • Approved Label: Not Available
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