Original New Drug Application Approvals by US FDA (01 - 15 April 2020)

15 Apr 2020
Original New Drug Application Approvals by US FDA (01 - 15 April 2020)
New drug applications approved by US FDA as of 01 - 15 April 2020 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.

KOSELUGO
  • Active Ingredient(s): Selumetinib
  • Strength: 10 mg; 25 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: AstraZeneca LP
  • Approval Date: 10 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Approved Label: 10 April 2020 (PDF)

HELIUM, USP
  • Active Ingredient(s): Not available
  • Strength: Not available
  • Dosage Form(s) / Route(s): Gas; inhalataion
  • Company: ILMO Products Company
  • Approval Date: 14 April 2020
  • Submission Classification: Medical Gas
  • Indication(s): Not available
  • Approved Label: Not available

JELMYTO
  • Active Ingredient(s): Mitomycin
  • Strength: Not available
  • Dosage Form(s) / Route(s): Solution; pyelocalyceal
  • Company: Urogen Pharma, Ltd.
  • Approval Date: 15 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
  • Approved Label: 15 April 2020 (PDF)