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

15 Apr 2021
New drug applications approved by US FDA as of 01-15 April 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.

QELBREE
  • Active Ingredient(s): Viloxazine Hydrochloride
  • Strength: EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE
  • Dosage Form(s) / Route(s): Capsule, Extended Release; Oral
  • Company: Supernus Pharms
  • Approval Date: 02 April 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age
  • Approved Label02 April 2021 (PDF)
BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 2.5MG/VIAL; 1MG/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous, Subcutaneous
  • Company: Hospira Inc
  • Approval Date: 14 April 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s):Not available
  • Approved Label: Not available
NEXTSTELLIS
  • Active Ingredient(s): Drospirenone; Estetrol
  • Strength: 3MG; 14.2MG
  • Dosage Form(s) / Route(s): Tablet, Chewable, Tablet, Capsule; Oral
  • Company: Mayne Pharma
  • Approval Date: 15 April 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):  Indicated for use by females of reproductive potential to prevent pregnancy
  • Approved Label15 April 2021 (PDF)
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