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Richmond Times - Dispatch

Ouch!

After some retailers advertised that a stronger dosage of pain reliever Advil would hit their store shelves soon, drugmaker 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.

However, the FDA told Wyeth on Sept. 14 that 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 New York Times. The ads are also running in Atlanta, Chicago, Dallas, Los Angeles and Miami.

The ads state: "Any notice of the availability of Advil Maximum Strength was in error. Advil Maximum Strength is not available for sale. We apologize to our retailers and their shoppers."

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 Advil line also includes lower-dose children's products, 200-milligram Advil Migraine and combination versions to relieve pain and symptoms of colds or allergies.

The new product would be in a 400-milligram dose.

Originally published by The Associated Press.

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