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FDA registration

Tadalafil (on-demand and daily) and brand-name Cialis Once-daily tadalafil is not only for erectile dysfunction, but has also been FDA-approved for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) a common comorbidity in older men

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However, at this stage, following comparison of what is available with minimal data sets, consideration is normally given to further searching, further requests for information to industry, and the use of modelling or default values to fill data gaps