Original New Drug Application Approvals by US FDA (16-31 July 2023)

02 Aug 2023
Original New Drug Application Approvals by US FDA (16-31 July 2023)
New drug applications approved by US FDA as of 16-31 July 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.

BEYFORTUS
  • Active Ingredient(s): Nirsevimab-alip
  • Strength: 50MG; 100MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Astrazeneca AB
  • Approval Date: 17 July 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the prevention of RSV lower respiratory tract disease in:
    • Neonates and infants born during or entering their first RSV season.
    • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
  • Approved Label:  17 July 2023 (PDF)
VANFLYTA
  • Active Ingredient(s): Quizartinib Dihydrochloride
  • Strength: EQ 17.7MG BASE; EQ 26.5MG BASE
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Daiichi Sankyo Inc
  • Approval Date: 20 July 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

    Limitations of Use:
    VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
  • Approved Label:  20 July 2023 (PDF)
YCANTH
  • Active Ingredient(s): Cantharidin
  • Strength: 0.7%
  • Dosage Form(s) / Route(s): Solution;topical
  • Company: Verrica Pharms
  • Approval Date: 21 July 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.
  • Approved Label:  21 July 2023 (PDF)
XDEMVY
  • Active Ingredient(s): Lotilaner
  • Strength: 0.25%
  • Dosage Form(s) / Route(s): Solution/drops;ophthalmic
  • Company: Tarsus Pharmaceuticals, Inc.
  • Approval Date: 24 July 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Demodex blepharitis.
  • Approved Label:  24 July 2023 (PDF)
MEROPENEM
  • Active Ingredient(s): Meropenem
  • Strength: 2G/VIAL
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: HQ Speclt Pharma
  • Approval Date: 26 July 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only.
  • Approved Label:  26 July 2023 (PDF)
RIVIVE
  • Active Ingredient(s): Naloxone Hydrochloride
  • Strength: 3MG/0.1ML
  • Dosage Form(s) / Route(s): Spray;nasal
  • Company: Harm Reduction Therapeutics
  • Approval Date: 28 July 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): NA
  • Approved Label: NA