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FDA Approves New Cialis Dosage


Cialis maker Eli Lilly and Co. has received approval to offer its erectile dysfunction drug in a new once-daily dose.

The Food and Drug Administration has approved once-daily formulations of Cialis, in dosages of 2.5 milligrams and 5 milligrams, that will allow men to be more spontaneous and enjoy sex any time between doses.

Lilly officials say the new tablets, which are also available in parts of Europe, provide “a new option for men… that can be taken without regard to timing of sexual activity.” Shawn Heffern, Lilly’s U.S. marketing director, says that with the daily dose, men will not need to take Cialis in anticipation of sex because it is already in their system.

“They’ve got a lot of pressure to perform, and the worst thing we can do is then put some limited amount of time … where they need to have sex or otherwise it’s out of their system and doesn’t work,” he said.

The low dose daily treatment option is designed for men who anticipate more frequent sexual activity, for example, having sex twice a week or more. Lilly’s wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed, so that patients who currently use two or more pills per week of as-needed Cialis should not experience higher costs with once-daily Cialis.

Cialis 5 mg, 10 mg and 20 mg have been approved in the United States for as-needed treatment of ED since November 2003. At these higher doses, the drug has proven to provide sustained efficacy for up to 36 hours.

Viagra and another erectile dysfunction drug, Levitra, also can be taken daily, but Cialis is the only drug specifically approved for a daily treatment regimen.

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