The drug is not approved for children under age 6.
How do I find out if a drug is approved?
The drug was approved in 2002, and sales were $45.1 million last year.
The committee was not asked to vote on whether the drug should be approved.
But no new drug has been approved for almost a decade.
In September 2011, the first drug was approved under this process.
With additional data, the drug was approved earlier this year.
The drug is approved and used in a number of countries worldwide.
The drug has since been approved as a treatment for head and neck cancer.
But later, after the drug is approved, far more people take it, sometimes along with other drugs, and individual differences begin to show up.