TRENTON, N.J. - After some retailers advertised that a stronger dosage of pain reliever Advil would hit their store shelves soon, drug maker Wyeth is running newspaper ads saying the product is not available.
The problem? The Food and Drug Administration has not given approval for sales of Advil Maximum Strength.
Madison, N.J.-based Wyeth had notified some retailers that distribution of the new product was "imminent," and a few retailers this month promoted it in store fliers, Wyeth spokesman Doug Petkus said yesterday.
But the FDA told Wyeth on Sept. 14 it must meet certain conditions before the agency can approve sale of the product.
"We have some items to address," Petkus said.
He declined to identify those items or say which retailers ran notices the product would be for sale soon.
"We're optimistic that within a short period of time we'll get approval," he said.
The Wyeth ads are running in daily newspapers in about 25 major markets, including a half-page ad in yesterday's editions of The Boston Globe and The New York Times. The ads are also running in Atlanta, Chicago, Dallas, Los Angeles, and Miami.
Advil is Wyeth's brand of the popular, nonsteroidal anti-inflammatory drug ibuprofen.
Currently, Wyeth sells Advil in tablet, caplet, and gel caplet forms, all in a 200-milligram dose.
The new product would be in a 400-milligram dose.