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FDA Approves Another Drug For Erectile Dysfunction

Cialis To Be Available In Pharmacies Within Weeks

5:43 p.m. EST November 21, 2003

What's known in Europe as "the weekend" pill is the latest impotence drug to receive U.S. approval.

The Food and Drug Administration says Eli Lilly's Cialis was backed by studies that found some men benefited for three days at a time. The drug, which is sold widely in Europe, is taken orally and stays in the body longer than others on the market. The FDA says Cialis should not be used more than once a day.

Cialis is the third similar drug to receive FDA approval, after Viagra and Levitra. Cialis relaxes muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

The drug will be available in pharmacies in early December, according to Eli Lilly.

The FDA's approval comes with some conditions to avoid adverse reactions with other drugs, including some heart disease and high blood pressure medications.

The most common side effects include headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. Patients who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis and these usually go away by themselves within 48 hours. A small number of patients taking Cialis also reported abnormal vision.