Original New Drug Application Approvals by US FDA (01-15 May 2023)

16 May 2023
Original New Drug Application Approvals by US FDA (01-15 May 2023)
New drug applications approved by US FDA as of 01-15 May 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.

LUMRYZ
  • Active Ingredient(s): Sodium Oxybate
  • Strength: 4.5GM/PACKET, 6GM/PACKET, 7.5GM/PACKET, 9GM/PACKET
  • Dosage Form(s) / Route(s): For Suspension, Extended Release;oral
  • Company: Avadel Cns
  • Approval Date: 01 May 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
  • Approved Label:  01 May (PDF)
MOTPOLY XR
  • Active Ingredient(s): Lacosamide
  • Strength: 100MG, 150MG, 200MG
  • Dosage Form(s) / Route(s): Capsule, Extended Release;oral
  • Company: Aucta
  • Approval Date: 04 May 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
  • Approved Label:  04 May (PDF)
MYDCOMBI
  • Active Ingredient(s): Phenylephrine Hydrochloride; Tropicamide
  • Strength: 2.5%;1%
  • Dosage Form(s) / Route(s): Spray, Metered;ophthalmic
  • Company: Eyenovia
  • Approval Date: 05 May 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.
  • Approved Label:  05 May (PDF)
CEFAZOLIN
  • Active Ingredient(s): Cefazolin
  • Strength: 2G/VIAL
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: HA Spclt Pharma
  • Approval Date: 08 May 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for perioperative prophylaxis in adult patients.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  08 May (PDF)
ZOLPIDEM TARTRATE
  • Active Ingredient(s): Zolpidem Tartrate
  • Strength: 7.5MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Almatica
  • Approval Date: 09 May 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than age 65 years of age
  • Approved Label:  09 May (PDF)
ELFABRIO
  • Active Ingredient(s): Pegunigalsidase Alfa-iwxj
  • Strength: 20MG/10ML
  • Dosage Form(s) / Route(s): Vial; Single-use
  • Company: Chiesi Farmaceutici Spa
  • Approval Date: 09 May 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adults with confirmed Fabry disease.
  • Approved Label:  09 May (PDF)
VEOZAH
  • Active Ingredient(s): Fezolinetant
  • Strength: 45MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Asteellas Pharma Us, Inc.
  • Approval Date: 12 May 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
  • Approved Label:  12 May (PDF)