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

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

AYVAKIT
  • Active Ingredient(s): Avapritinib
  • Strength: 100 mg; 200 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Blueprint Medicines Corp
  • Approval Date: 09 January 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
  • Approved Label: 09 January 2020 (PDF)

VALTOCO
  • Active Ingredient(s): Diazepam
  • Strength: 5 mg; 7.5 mg; 10 mg
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Neurelis, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
  • Approved Label: 10 January 2020 (PDF)

NUMBRINO
  • Active Ingredient(s): Cocaine hydrochloride
  • Strength: 40 mg/mL
  • Dosage Form(s) / Route(s): Solution; nasal
  • Company: Cody Laboratories, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
  • Approved Label: 10 January 2020 (PDF)