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Original New Drug Application Approvals by US FDA (01 - 15 April 2020)
15 Apr 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
HELIUM, USP
JELMYTO
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)
