The Food and Drug Administration has cleared a product label addition for Cialis, Eli Lilly & Co.'s drug for erectile dysfunction and symptoms of enlarged prostate.


Cialis, Eli Lilly, product label addition, Food and Drug Administration, FDA, tadalafil, erectile dysfunction, enlarged prostate, benign prostatic hyperplasia, BPH, ED, Claus Roehrborn




























































































































































































































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Cialis label addition approved by FDA

October 25th, 2013

INDIANAPOLIS – The Food and Drug Administration has cleared a product label addition for Cialis, Eli Lilly & Co.'s drug for erectile dysfunction and symptoms of enlarged prostate.

Lilly said Friday that the label addition includes data from a 26-week study showing that taking Cialis (tadalafil) 5 mg once daily, started in combination with finasteride, significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as four weeks, compared to placebo with finasteride, in men with BPH and an enlarged prostate.

Cialis is approved by the FDA to treat erectile dysfunction (ED), the signs and symptoms of BPH. BPH is a condition in which the prostate enlarges and can cause urinary symptoms such as the need to urinate urgently and frequently. Finasteride is a type II 5 alpha-reductase inhibitor (5-ARI) approved by the FDA for the treatment of BPH in men with an enlarged prostate.

If Cialis is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks, according to Lilly.

"Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months," stated Claus Roehrborn, chairman, of the urology department at the University of Texas Southwestern Medical Center. "These data demonstrate that the combination of Cialis 5 mg for once daily use with finasteride leads to symptom improvement as early as four weeks in men with BPH and an enlarged prostate. This means that Cialis 5 mg for once daily use can be an effective option for early symptom relief when started in combination with finasteride."

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