Share this article

print logo

FDA TELLS MERCK IT WANTS MORE DATA ON NEW DRUG

The Food and Drug Administration told Merck & Co. that it requires further safety and efficacy data before it will approve Arcoxia, the successor drug to now defunct pain reliever Vioxx, the pharmaceutical maker announced Friday.

Merck pulled Vioxx from the market last month after a study showed it doubled patients' risk of heart attacks and strokes.

The FDA sent Merck an "approvable letter," which means the drug must meet more standards before it gets the green light.

Last week, Merck released a study for Arcoxia that found there was no statistical difference in adverse cardiovascular events between it and diclofenac, an older pain reliever.

There are no comments - be the first to comment