FDA Approvals | Recombinant protein
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
- insulin human (25)
- somatropin (17)
- Filgrastim (12)
- antihemophilic factor viii (Recombinant) (11)
- insulin lispro (11)
Top 5 generic ingredients
- lutropin alpha (2)
Top 5 innovator sponsors
- Novo Nordisk (27)
- Eli Lilly (15)
- Takeda (13)
- Sanofi-Aventis (11)
- Merck Serono (8)
Top 5 generic sponsors
- Ferring (2)
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 |
|---|---|---|---|---|---|---|
| somatropin | Serono | 1976 - 2008 | 1976 - 2008 | 17 | 0 | Recombinant protein |
| insulin human | Eli Lilly | 1982 - 2019 | 1982 - 2019 | 25 | 0 | Recombinant protein |
| interferon alpha-2a | Roche | 1986 - 2004 | 1986 - 2004 | 2 | 0 | Recombinant protein |
| interferon alpha-2b | Merck | 1986 - 2008 | 1986 - 2008 | 4 | 0 | Recombinant protein |
| alteplase | Genentech | 1987 | 1987 | 1 | 0 | Recombinant protein |
| epoetin | Amgen | 1989 - 2018 | 1989 - 2018 | 2 | 0 | Recombinant protein |
| interferon alfa-n3 | Hemispherx Biopharma | 1989 | 1989 | 1 | 0 | Recombinant protein |
| human coagulation factor ix | Grifols | 1990 - 2000 | 1990 - 2000 | 2 | 0 | Recombinant protein |
| sargramostim | Amgen | 1991 - 2015 | 1991 - 2015 | 3 | 0 | Recombinant protein |
| aldesleukin | Clinigen, Inc. | 1992 | 1992 | 1 | 0 | Recombinant protein |
| alglucerase | Genzyme | 1992 | 1992 | 1 | 0 | Recombinant protein |
| antihemophilic factor viii (Recombinant) | Takeda | 1992 - 2019 | 1992 - 2019 | 11 | 0 | Recombinant protein |
| dornase alfa | Genentech | 1993 | 1993 | 1 | 0 | Recombinant protein |
| interferon beta-1b | Bayer | 1993 - 2009 | 1993 - 2009 | 2 | 0 | Recombinant protein |
| imiglucerase | Genzyme | 1994 - 2010 | 1994 - 2010 | 2 | 0 | Recombinant protein |
| lutropin alpha | Organon | 1994 - 2014 | 1994 - 2014 | 4 | 2 | Recombinant protein |
| insulin lispro | Eli Lilly | 1996 - 2020 | 1996 - 2020 | 11 | 0 | Recombinant protein |
| interferon beta-1a | Biogen | 1996 - 2002 | 1996 - 2002 | 2 | 0 | Recombinant protein |
| reteplase | Chiesi | 1996 | 1996 | 1 | 0 | Recombinant protein |
| becaplermin | Smith & Nephew | 1997 | 1997 | 1 | 0 | Recombinant protein |
102 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