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Letter to FDA Commissioner Hamburg on Generic Abuse-Deterrent Formulations of Prescription Opioid Products


Excerpt: However, despite these positive steps, we continue to be concerned about the lack of a clear statement from FDA regarding the agency’s intention to prevent the marketing of non-abuse-deterrent generic versions of innovator products that have been withdrawn from the market and replaced with abuse-deterrent formulations.

To read the letter, click here.

To read FDA’s April 16, 2013, response, click here.