sábado, 16 de diciembre de 2017
FDA updates list of off-patent, off-exclusivity drugs without an approved generic
Today, the U.S. Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.”
The list includes approved new drug applications (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The methodology used to compile the first edition of the list (published June 2017) has been modified to reflect that the list is now based on drug products, not active ingredients. This means that an approved NDA in the active section of FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for a particular active ingredient and dosage form is included on the list if there are no approved ANDAs for such an NDA, even if there are approved ANDAs that reference a different NDA with the same active ingredient.
The agency maintains this list to improve transparency and encourage the development and submission of ANDAs in markets with little competition. The agency will continue to refine and periodically update the list to ensure continued transparency regarding drug categories where increased competition has the potential to provide significant benefit to patients.
In addition, the FDA intends to work with the U.S. Pharmacopeial Convention (USP) to maximize the utility of this list. The FDA-USP relationship is longstanding, and since 2010, the FDA has actively collaborated with USP in support of modernizing scientific standards for drug product development. The FDA intends to further this successful collaboration by working with USP to consider modernizing standards for the drug products on this list to continue to advance the development of generic medicines.