FDA Approves New Indications For Erectile Dysfunction Drug Cialis

The Food and Drug Administration Oct. 6 approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously.

Cialis, which is manufactured by Indianapolis-based Eli Lilly and Co., was approved in 2003 for the treatment of ED (1 PLIR 1292, 12/5/03). Common symptoms of BPH include difficulty in starting urination and a weak urine stream, a sudden urge to urinate, and more frequent urination, including at night, the agency said.

“BPH ...