FDA Approvals | Biological
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
- glucagon (6)
- human choriogonadotropin alfa (5)
- corticotropin (3)
- urofollitropin (2)
- thyroglobulin (1)
Top 5 innovator sponsors
- Grifols (21)
- CSL Behring (14)
- Takeda (9)
- Octapharma (8)
- Kamada, Ltd. (6)
Top 5 generic sponsors
- Athenex, Inc. (7)
- Mylan (2)
- Ferring (2)
- Impax Laboratories (1)
- Cipla (1)
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
69 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