Oral painkiller approved in line with FDA's unapproved drugs initiative

ROCKVILLE, Md. The Food and Drug Administration has given the green light to an oral painkiller as part of its unapproved drugs initiative, the agency announced Tuesday.

The FDA approved Roxane Labs’ morphine sulfate oral solution in the 100-mg-per-5 milliliter and 20-mg-per-milliliter strengths for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients.

The FDA granted the approval under a program that began in March 2009 to regulate so-called “grandfathered” drugs – mostly narcotics – that have long been prescribed without approval because they entered the market before the agency adopted its current regulatory policies.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton said. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”