FDA dials back safety restrictions on Avandia

Share this article:

The FDA said it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Its actions are consistent with the recommendations of expert advisory committees.

“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. “Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.”

The agency had placed restrictions on the med following a two-year Senate inquiry, results of which were released in 2010.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Massachusetts painkiller ban overruled

A District Court says Massachusetts cannot ban opioid painkiller Zohydro.

Ranbaxy extends branded Diovan's life

Ranbaxy may be on the blocks, but it has a hold on the right to produce generics of the Novartis heart medication Diovan. Only problem: it can't, and that is good news for Novartis.

FDA approves Glaxo's GLP-1

Type-2 diabetes injection Tanzeum, also known as albiglutide, scored the approval Tuesday.