Original New Drug Application Approvals by US FDA (01 - 15 September 2022)

15 Sep 2022
Original New Drug Application Approvals by US FDA (01 - 15 September 2022)
New drug applications approved by US FDA as of 01 - 15 September 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.

STIMUFEND
  • Active Ingredient(s): Pegfilgrastim-fpgk
  • Strength: 6MG/0.6ML
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Fresenius Kabi Usa
  • Approval Date: 01 September 2022
  • Submission Classification: N/A
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label:  01 September (PDF)
SPEVIGO
  • Active Ingredient(s): Spesolimab-sbzo
  • Strength: 900MG
  • Dosage Form(s) / Route(s): Injectable;Intravenous
  • Company: Boehringer Ingelheim Pharmaceuticals Inc
  • Approval Date: 01 September 2022
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of generalized pustular psoriasis flares in adults.
  • Approved Label:  01 September (PDF)
DAXXIFY
  • Active Ingredient(s): Daxibotulinumtoxina-lanm
  • Strength: 0.1ML
  • Dosage Form(s) / Route(s): Injectable;Intramuscular, Subcutaneous
  • Company: Revance Therapeutics, Inc.
  • Approval Date: 07 September 2022
  • Submission Classification: N/A
  • Indication(s): Indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
  • Approved Label:  07 September (PDF)
SOTYKTU
  • Active Ingredient(s): Deucravacitinib
  • Strength: 6MG (3)
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Bristol-Myers Squibb
  • Approval Date: 09 September 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
  • Approved Label:  09 September (PDF)
ROLVEDON
  • Active Ingredient(s): Eflapegrastim-xnst
  • Strength: 13.2MG/0.6ML
  • Dosage Form(s) / Route(s): Injectable;Subcutaneous
  • Company: Spectrum Pharms
  • Approval Date: 09 September 2022
  • Submission Classification: N/A
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. 
  • Approved Label: 09 September (PDF)
TERLIVAZ
  • Active Ingredient(s): Terlipressin
  • Strength: 0.85MG
  • Dosage Form(s) / Route(s): Injectable;Injection
  • Company: Mallinckrodt
  • Approval Date: 14 September 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Approved Label:  14 September (PDF)