Original New Drug Application Approvals by US FDA (01-15 September 2021)

20 Sep 2021
New drug applications approved by US FDA as of 01-15 September 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.

TRUDHESA
  • Active Ingredient(s): Dihydroergotamine Mesylate
  • Strength: 0.725MG/SPRAY
  • Dosage Form(s) / Route(s): Spray, Metered; Nasal
  • Company: Impel Neuropharma
  • Approval Date: 02 September 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label: 02 September 2021 (PDF)
EXKIVITY
  • Active Ingredient(s):  Mobocertinib
  • Strength: 40MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Takeda Pharms USA
  • Approval Date: 15 September 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
  • Approved Label: 15 September 2021(PDF)
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