Eli Lilly and Company initiated Cialis development in the late 1990s. Researchers focused on creating a PDE5 inhibitor with a longer half-life than Viagra, aiming for improved efficacy and convenience. Preclinical studies rigorously tested Cialis’s safety and potential benefits.
Extensive clinical trials followed, evaluating Cialis’s effectiveness in treating erectile dysfunction (ED) across diverse patient populations. These trials meticulously documented efficacy rates, side effects, and interactions with other medications. Researchers carefully analyzed data to determine optimal dosages and treatment protocols.
Lilly submitted a comprehensive New Drug Application (NDA) to the Food and Drug Administration (FDA) in 2002. The FDA reviewed the data thoroughly, assessing Cialis’s safety, efficacy, and quality. The review process included evaluations of manufacturing processes and labeling information.
Following a detailed review, the FDA approved Cialis for the treatment of ED in November 2003. This approval marked a significant advancement in ED treatment, providing patients with a longer-lasting option. Subsequent studies led to additional approvals for Cialis’s use in treating benign prostatic hyperplasia (BPH).
Note: This information is for educational purposes only and should not be considered medical advice. Consult a healthcare professional for guidance on ED or BPH treatment.
