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Pharmaceuticals / Inspections and Audits

FDA Updates List of Off-Patent, Off-Exclusivity Drugs With No Approved Generics

June 28, 2018

The FDA issued an update to its list of off-patent, off-exclusivity drugs with no approved generic competitors.

The list is split into two parts. Part I identifies drug products that the FDA could immediately accept an ANDA for without prior discussion, while Part II lists products for which ANDA development could bring up possible regulatory, legal or scientific issues that should be discussed with the agency before submission of the ANDA.

To facilitate the discussion for products in Part II, sponsors should submit an inquiry to the Office of Generic Drugs.

Sponsors may be referred to the Office of New Drugs if the product is a biological product or if it is not eligible for submission or approval as an ANDA but may be suited for another pathway.

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