FDA approval history for Cialis (tadalafil) used to treat Erectile Dysfunction, Benign Prostatic Hyperplasia. Supplied by Eli Lilly and Co. Approved FDA drug approval for Cialis by Unit Dose Services. View regulatory information, product details, labeling, and manufacturer information. FDA Structured Product Label (SPL) for Cialis (NDC 0002-4465). Review professional prescribing information, including 1.1 erectile dysfunction, 1.2 benign See FDA-Approved Patient Labeling (Patient Information) Inform patients of contraindication of tadalafil tablets with any use of organic nitrates or GC stimulators. Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). The Fast Facts All FDA-approved erectile dysfunction (ED) pills (sildenafil, tadalafil, vardenafil, and avanafil) are generally safe and effective when taken as prescribed. There are four main FDA-approved erectile dysfunction (ED) drugs: sildenafil (Viagra), tadalafil (Cialis), vardenafil, and avanafil (Stendra). Which one is the best choice for a man depends on his lifestyle and whether he takes medication that ED drugs may interfere with. Systemic drug exposures, as measured by AUC of unbound tadalafil, were approximately 10-fold for mice, and 14- and 26-fold for male and female rats, respectively, the exposures in human males given Maximum Recommended Human Dose (MRHD) of 20 mg. The US FDA has removed the clinical hold on a trial of Cialis (tadalafil) by Sanofi's consumer healthcare business, Opella. Eli Lilly and Company: CIALIS is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) (1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and. CIALIS for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].