Erectile Dysfunction

On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis approximately thirty minutes prior to sexual activity. While several drugs used to treat ED are already on the market, including Viagra (sildenafil citrate) and Cialis (tadalafil), this recent approval marks the expansion of treatment options for those with ED. Under the FDA’s regulatory regime, drug sponsors must demonstrate that a drug is safe and effective for its intended use in…