FDA Approves Lilly's Cialis

Cialis (tadalafil) relaxes muscles and increases blood flow to particular areas of the body.

Cialis is used to treat erectile dysfunction (impotence) in men. Adcirca, another brand of tadalafil, is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

CIALIS for daily use is a clinically proven, low-dose tablet that you take every day for erectile dysfunction (ED) to help improve erections. When taken at about the same time every day, it can be an effective option no matter how severe your ED may be. CIALIS for daily use can also help treat ED in men who have other health problems, such as heart disease, diabetes, and high cholesterol. Only you and your doctor can decide if CIALIS is right for you.

Tadalafil is a PDE5 inhibitor, currently marketed in pill form for treating erectile dysfunction (ED) under the name Cialis; it has recently been approved for the treatment of pulmonary arterial hypertension, and has been used for other conditions. It initially was developed by the biotechnology company ICOS, and then again developed and marketed world-wide by Lilly ICOS, LLC, the joint venture of ICOS Corporation and Eli Lilly and Company. Cialis tablets, in 5 mg, 10 mg, and 20 mg doses, are yellow, film-coated, and almond-shaped. The approved dose for pulmonary arterial hypertension is 40 mg, and is marketed under the brand name Adcirca.

In December 2002, the Food and Drug Administration approved tadalafil (as Cialis) for sale in the United States as the third ED prescription drug pill (after sildenafil citrate (Viagra) and vardenafil (Levitra)). Cialis's 36-hour effectiveness earned it the nickname, "The Weekend Pill"; like sildenafil and vardenafil, tadalafil is recommended as an 'as needed' medication. Cialis is the only one of the three that is also offered as a once-daily medication.

Moreover, tadalafil was approved in May 2009 in the United States for the treatment of pulmonary arterial hypertension and is currently under regulatory review in other regions for this condition. In late November 2008, Eli Lilly sold the exclusive rights to commercialize tadalafil for pulmonary arterial hypertension in the United States to United Therapeutics for an upfront payment of $150 million.

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction) by blocking a certain enzyme (phosphodiesterase-PDE5) in the body. In combination with sexual stimulation, tadalafil helps blood flow into the penis to achieve and maintain an erection.

This drug is not indicated for use in women.

Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.