The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have turned their attention to companies illegally marketing products to help with opioid withdrawal and addiction. The agencies sent letters to the marketers and distributors of the products with warnings about their...

In the latest step taken by the US Food and Drug Administration (FDA) to address the nation's opioid abuse epidemic, the agency has changed the indication of cough medicines containing opioids to exclude all pediatric patients.  Following the latest safety labeling changes, opioid cough and...

The US Food and Drug Administration has granted approval to Sublocade (buprenorphine extended release) for the treatment of patients with moderate to severe opioid use disorder. Shaun Thaxter, chief executive officer of Indivior, described the approval as an “important step forward for...

The US Food and Drug Administration (FDA) is looking into improved packaging, storage and disposal strategies to address the opioid abuse epidemic in the United States. In a statement released at the end of October, FDA Commissioner Scott Gottlieb, MD, reaffirmed the regulatory body's...

Scott Gottlieb, MD, US Food and Drug Administration (FDA) Commissioner, has outlined the FDA's plans to tackle the nation's opioid abuse epidemic. Speaking to the House Committee on Energy and Commerce Hearing, he described opioid addiction as the "biggest crisis facing public health...

Endo International is reviewing a request from the US Food & Drug Administration (FDA) to remove the opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market. The government body's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products...

A new formulation of the opioid oxycodone has been approved by the US Food & Drug Administration (FDA), providing doctors with a new option for treating patients in pain. RoxyBond (oxycodone hydrochloride) is the first immediate-release opioid analgesic with labeling for abuse-deterrent...