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
- eteplirsen (1)
- tofersen (1)
- Imetelstat (1)
- pegaptanib (1)
- vutrisiran (1)
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 Ingredient | Innovator Sponsor | Approval Years | Innovator Years | Innovator | Generic | Type |
|---|---|---|---|---|---|---|
| pegaptanib | Bausch & Lomb | 2004 | 2004 | 1 | 0 | Nucleic acid |
| mipomersen | Kastle Therapeutics, LLC | 2013 | 2013 | 1 | 0 | Nucleic acid |
| eteplirsen | Sarepta Therapeutics | 2016 | 2016 | 1 | 0 | Nucleic acid |
| inotersen | Akcea Therapeutics | 2018 | 2018 | 1 | 0 | Nucleic acid |
| patisiran | Alnylam Pharmaceuticals | 2018 | 2018 | 1 | 0 | Nucleic acid |
| givosiran | Alnylam Pharmaceuticals | 2019 | 2019 | 1 | 0 | Nucleic acid |
| lumasiran | Alnylam Pharmaceuticals | 2020 | 2020 | 1 | 0 | Nucleic acid |
| viltolarsen | Nippon Shinyaku Co Ltd | 2020 | 2020 | 1 | 0 | Nucleic acid |
| vutrisiran | Alnylam Pharmaceuticals | 2022 | 2022 | 1 | 0 | Nucleic acid |
| nedosiran | Novo Nordisk | 2023 | 2023 | 1 | 0 | Nucleic acid |
| tofersen | Biogen-IDEC | 2023 | 2023 | 1 | 0 | Nucleic acid |
| Imetelstat | Geron Corporation | 2024 | 2024 | 1 | 0 | Nucleic acid |
| olezarsen | Ionis Pharmaceuticals, Inc. | 2024 | 2024 | 1 | 0 | Nucleic acid |
| donidalorsen | Ionis Pharmaceuticals, Inc. | 2025 | 2025 | 1 | 0 | Nucleic acid |
| fitusiran | Sanofi-Aventis | 2025 | 2025 | 1 | 0 | Nucleic acid |
| plozasiran | Arrowhead Pharmaceuticals | 2025 | 2025 | 1 | 0 | Nucleic acid |
16 ingredients
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Sponsor Organizations
| Sponsor | Approval Years | Innovator Years | Innovator | Generic | Org Type |
|---|
Approval Applications
| Appl No | Type | Approval | Sponsor | Active Ingredients | Marketing Status | Class | Priority? | 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