Sanofi, Lilly Pursue OTC ED Drug Approval

Sanofi and Eli Lilly and Company have announced an agreement to pursue FDA approval of Cialis (tadalafil; Eli Lilly and Company) as an over-the-counter treatment for erectile dysfunction (ED).

Under this agreement, Sanofi gains the exclusive rights to apply for regulatory approval of Cialis OTC in the U.S., Europe, Canada, and Australia and the exclusive rights to market Cialis OTC following all required regulatory approvals.

Cialis is a phosphodiesterase type 5 inhibitor (cGMP-specific) indicated to treat ED, the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. It is currently available only by prescription for men ages ≥18 and is offered as 2.5mg, 5mg, 10mg, and 20mg tablets.

For more information visit Sanofi.com or Lilly.com.

Want to read more?