FDA Gives OK To Wyeth’s Pristiq

The U.S. Food And Drug Administration has approved Wyeth’s new antidepressant Pristiq.

Pristiq is the successor to Effexor, which accounted for about seventeen percent of Wyeth’s total revenue with sales of $3.8 billion. 

Since generics are expected to chip into that profit margin, a new antidepressant with the benefit of patent protection will certainly help the company’s bottom line.

It’s not the end of the line for FDA evaluation, however.  Approval was conditional on the drugmaker agreeing to multiple post-marketing commitments, which will include submission of data from multiple studies.

“PRISTIQ is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression,” said Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience.

“PRISTIQ is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.”