U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Postmarket Drug Safety Information for Patients and Providers
  5. Information Page: FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
  1. Postmarket Drug Safety Information for Patients and Providers

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 Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.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

 

Related Information

Back to Top