The agency required an additional safety study before it would approve the drug.

"It's our fundamental power to approve drugs before they come on the market."

To my mind, it would be very dangerous to have approved the drug at this time.

Instead, we'll approve the drug for adults and then require studies in children.

The number was small because state Medicaid programs, which serve the poor, delayed approving the drug.

Enforcing the law and approving new drugs are two examples.

The study also examined how long it took to approve drugs made of new chemical compounds.

The agency has until Sept. 30 to either approve the drug, reject it or call for a further delay.

In March, an advisory panel recommended that the agency approve the drug for children.

It is believed to be the first citizen petition to call for the agency to move quickly to approve drugs.