FDA Approvals | Nucleic acid

Products regulated by the Food and Drug Administration comprise 25% of American consumer spending. The approaches used to approve these products can be as varied and complex as the products themselves. Such differences are dictated by Federal law and FDA identifies and enforces the relative risks and benefits that the products pose to consumers. These results convey summaries of products approved by FDA, including information about their past history and present status. The information not only applies to New Molecular Entities, but includes FDA approval information pertaining to new ingredients, dosages, therapeutic uses and generic equivalents.

Top 5 innovator ingredients

Top 5 generic ingredients

  • None

Top 5 innovator sponsors

Top 5 generic sponsors

  • None

Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

Active Ingredients

Active IngredientInnovator SponsorApproval YearsInnovator YearsInnovatorGenericType
pegaptanibBausch & Lomb2004200410Nucleic acid
mipomersenKastle Therapeutics, LLC2013201310Nucleic acid
eteplirsenSarepta Therapeutics2016201610Nucleic acid
inotersenAkcea Therapeutics2018201810Nucleic acid
patisiranAlnylam Pharmaceuticals2018201810Nucleic acid
givosiranAlnylam Pharmaceuticals2019201910Nucleic acid
lumasiranAlnylam Pharmaceuticals2020202010Nucleic acid
viltolarsenNippon Shinyaku Co Ltd2020202010Nucleic acid
vutrisiranAlnylam Pharmaceuticals2022202210Nucleic acid
nedosiranNovo Nordisk2023202310Nucleic acid
tofersenBiogen-IDEC2023202310Nucleic acid
ImetelstatGeron Corporation2024202410Nucleic acid
olezarsenIonis Pharmaceuticals, Inc.2024202410Nucleic acid
donidalorsenIonis Pharmaceuticals, Inc.2025202510Nucleic acid
fitusiranSanofi-Aventis2025202510Nucleic acid
plozasiranArrowhead Pharmaceuticals2025202510Nucleic acid
16 ingredients
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Approval Applications

Appl NoTypeApprovalSponsorActive IngredientsMarketing StatusClassPriority?Links

Submission class glossary

TYPE 1
New Molecular Entity
TYPE 2
New Active Ingredient
TYPE 3
New Dosage Form
TYPE 4
New Combination
TYPE 5
New Formulation or New Manufacturer
TYPE 6
New Indication (pre-2009)
TYPE 7
Drug Already Marketed without Approved NDA
TYPE 8
Partial Rx to OTC Switch
TYPE 9
New Indication or Claim (existing NDA)
TYPE 10
New Indication or Claim (additional NDA)
MEDGAS
Medical Gas