FDA Takes More Time on Broader Cymbalta Approval

The Food and Drug Administration is saying “not so fast” when it comes to a request by the makers of the antidepressant Cymbalta to approve the blockbuster drug for treating chronic pain.

The FDA has cancelled a Jan. 28 meeting of an advisory panel which had been set to consider the request. The agency said the meeting was cancelled “to allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication,” according to a Reuters news report.

“The agency intends to continue evaluating the application and, as needed, will announce future meeting dates,” the FDA said, according to Reuters.

The FDA often asks panels of medical experts to review new-drug approvals or requests for new approvals of existing drugs and make a recommendation to the agency. The FDA is not required to follow the advice of its panels, but in most cases, it does.

Cymbalta is one of Eli Lilly and Co.’s top-selling drugs, earning nearly $2.7 billion in sales in 2008. The drug is known generically as duloxetine and FDA approved to treat depression, anxiety, fibromyalgia and nerve pain related to diabetes.

The drug also is often prescribed “off label” by doctors to treat other conditions. While physicians are free to prescribe approved drugs for unapproved treatments, drug companies are forbidden from marketing drugs for unapproved “off label” uses.

In many cases, unapproved uses of approved drugs are to blame for severe and deadly side effects, allergic reactions, and other adverse events associated with prescription drug use.

Lilly sought FDA approval for chronic pain in 2008, but withdrew the bid in November of that year. Lilly then resubmitted its FDA application in June 2009, Reuters reports.

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