FDA chief defends approval of hydrocodone drug

The head of the Food and Drug Administration says the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain.

Dr. Margaret Hamburg defended her agency's decision to clear the drug during questioning before a Senate committee on Thursday, saying the pill from Zogenix met the government's standards for safety and effectiveness.

Zohydro is the first pure version of hydrocodone, the most abused medication in the U.S. More than a half-dozen lawmakers have criticized the FDA's approval decision, questioning why Zohydro was not formulated to thwart drug abusers from snorting or injecting it.

Hamburg cautioned that such formulations are still in the early stages of development. To date, the FDA has only approved one medication with such features: OxyContin.

"Right now, unfortunately, the technology is poor," Hamburg said.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Sen. Joe Manchin seeks to block new painkiller

Mar 11, 2014

U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse.

US panel opposes pure hydrocodone painkiller

Dec 09, 2012

(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

Potent new painkiller stokes alarm in US

Mar 08, 2014

A potent new painkiller hit the US market this week, despite warnings from top experts that the drug may deliver a deadly setback in America's battle with opioid addiction.

Recommended for you

Generic form of nexium approved

3 hours ago

(HealthDay)—The first generic version of the heartburn drug Nexium (esomeprazole) has been approved by the U.S. Food and Drug Administration.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.