Information Page: FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
[11/20/2014] FDA approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.
November 20, 2014
- FDA News Release: FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties (FDA Archive)
- FDA Voice Blog: Additional progress on reducing the abuse of opioid pain relievers
- Hysingla ER Drug Details