Late onset hypogonadism is defined as clinical and biochemical syndrome characterized by older age, set of typical symptoms, and deficiency in serum testosterone levels.
The quality of life may be decreased and multiple organ systems may be adversely affected.
Prior to the start of testosterone substitution, there should be confirmation of low serum testosterone and a confirmation of need based on clinical findings.
Only if the potential benefit exceeds the risk, then replacement testosterone should be started.
New drug applications approved by US FDA as of 01 - 15 November 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.