Original New Drug Application Approvals by US FDA (16 - 30 November 2021)

06 Dec 2021
Original New Drug Application Approvals by US FDA (16 - 30 November 2021)
New drug applications approved by US FDA as of 16-30 November 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.

VOXZOGO
  • Active Ingredient(s): Vosoritide
  • Strength: 0.4MG/VIAL; 0.56MG/VIAL; 1.2MG/VIAL
  • Dosage Form(s) / Route(s): Powder; Subcutaneous
  • Company: Biomarin Pharm
  • Approval Date: 11 November 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label: 11 November 2021 (PDF)
FYARRO
  • Active Ingredient(s): Sirolimus Albumin-bound Nanoparticles
  • Strength: 100MG/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous
  • Company: Aadi Bioscience Inc
  • Approval Date: 22 November 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
  • Approved Label: 22 November 2021 (PDF)
LYVISPAH
  • Active Ingredient(s): Baclofen
  • Strength: 5MG; 10MG; 20MG
  • Dosage Form(s) / Route(s): Granule; Oral
  • Company: Saol Theraps Res Ltd
  • Approval Date: 22 November 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH may also be of some value in patient with spinal cord injuries and other spinal cord diseases. (1) 
  • Approved Label: 22 November 2021 (PDF)
LIVTENCITY
  • Active Ingredient(s): Maribavir
  • Strength: 400MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Takeda Pharms Usa
  • Approval Date: 23 November 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. 
  • Approved Label: 23 November 2021 (PDF)
CYTALUX
  • Active Ingredient(s): Pafolacianine
  • Strength: 43.2MG/1.6ML (2MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: On Target Labrotories, Inc.
  • Approval Date: 29 November 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions
  • Approved Label: 29 November 2021 (PDF)