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

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

APONVIE
  • Active Ingredient(s): Aprepitant
  • Strength: 32MG/4.4ML (7.2MG/ML)
  • Dosage Form(s) / Route(s): Emulsion; Intravenous
  • Company: Heron Theraps Inc
  • Approval Date: 16 Sep 2022
  • Submission Classification: Not available
  • Indication(s): Indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
  • Approved Label:  16 Sep 2022 (PDF)
PEDMARK
  • Active Ingredient(s): Sodium Thiosulfate
  • Strength: 12.5G;100ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Fennec Pharmaceuticals Inc
  • Approval Date: 20 Sep 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. 
  • Approved Label:  20 Sep 2022 (PDF)
OMLONTI
  • Active Ingredient(s): Omidenepag Isopropyl
  • Strength: 0.002%(0.02MG/ML)
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Santen
  • Approval Date: 22 Sep 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Approved Label:  22 Sep 2022 (PDF)
IHEEZO
  • Active Ingredient(s): Chloroprocaine Hydrochloride
  • Strength: 3%
  • Dosage Form(s) / Route(s): Gel; Ophthalmic
  • Company: Sintetica Sa
  • Approval Date: 27 Sep 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for ocular surface anesthesia.
  • Approved Label:  27 Sep 2022 (PDF)
VEGZELMA
  • Active Ingredient(s): Bevacizumab-adcd
  • Strength: 100MG/4ML(25MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Celltrion
  • Approval Date: 27 Sep 2022
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Metastatic colorectal cancer, in combination with intravenous fluorouracilbased chemotherapy for first- or second-line treatment. (1.1)
    • Metastatic colorectal cancer, in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Approved Label:  27 Sep 2022 (PDF)
RELYVRIO
  • Active Ingredient(s): Sodium Phenylbutyrate; Sodium Taurursodiol
  • Strength: 3G/1G
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Amylyx Pharms
  • Approval Date: 29 Sep 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
  • Approved Label:  29 Sep 2022 (PDF)
LYTGOBI
  • Active Ingredient(s): Futibatinib
  • Strength: 4MG
  • Dosage Form(s) / Route(s): Tablet, Film Coated
  • Company: Taiho Oncology
  • Approval Date: 30 Sep 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Not available
  • Approved Label: Not available