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updated 10/15/2003 6:04:17 PM ET 2003-10-15T22:04:17

The little blue pill has a new rival. GlaxoSmithKline PLC and Bayer AG won U.S. approval on Tuesday to sell the anti-impotence drug Levitra, setting the stage for a fierce battle with Viagra in a billion-dollar-plus market.

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The announcement, from the U.S. Food and Drug Administration, means that Levitra, an orange pill, will give American men their first oral alternative to Pfizer Inc.’s famous diamond-shaped blue Viagra, the pill that transformed impotence treatment after its 1998 debut.

Levitra is in the same family as Viagra. Both work by targeting an enzyme important for maintaining an erection. An estimated 30 million American men suffer some degree of impotence.

Levitra, made by Bayer AG and marketed by GlaxoSmithKline, recently began selling in Europe. A third impotence pill — Cialis, from Eli Lilly & Co. and Icos Corp. — also has European approval and is expected to hit U.S. pharmacies later this year.

There have been no published studies directly comparing the pills to determine advantages of each. But the potency, speed and duration of each drug are hotly disputed.

Levitra’s makers say a major plus is that it works quickly — men taking Levitra can have an erection in 16 minutes.

Pfizer has responded with studies showing half of men taking Viagra were able to have sex within 20 minutes.

With the new competition, urologists expect a boom in direct-to-consumer advertising that might entice more men suffering from impotence to visit a doctor and check out their options.

Like Viagra, Levitra comes with some serious warnings that dramatically limit the number of men eligible to take it.

The FDA said Levitra should never be used by men who:

Take nitrate-containing drugs for heart conditions.

Take medicines called alpha blockers, such as Cardura, for high blood pressure or enlarged prostate. The combination could cause plummeting blood pressure and fainting.

The FDA also said Levitra is not for patients with a rare heart condition known as QT prolongation because the drug could cause an abnormal heart beat.

Nor is it for men who suffered a recent heart attack or stroke who have very low blood pressure or uncontrolled high blood pressure.

For otherwise healthy men, Levitra’s main side effects were headache, flushing and a stuffy nose. About 2 percent became dizzy.

Men are advised to get a thorough physical exam before using Levitra for the first time, the FDA said.

The manufacturer said Levitra would be on pharmacy shelves within a few weeks but refused to release the price.

Sales of Viagra, which hit the market in 1998, totaled $1.7 billion last year. Even before it had competition, Pfizer Inc. made the pill one of the nation’s most heavily promoted drugs, spending $101 million on marketing in 2001 alone.

Bayer and Glaxo haven’t detailed their marketing plans for Levitra yet, but they are beginning a three-year sponsorship deal with the National Football League reported to be worth about $18 million.

The Associated Press and Reuters contributed to this report.

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