FDA Approvals | Gene therapy

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.

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.