Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake inhibitor (SNRI) being studied as a treatment for adult patients with major depressive disorder.
The press release states four conditions:
- A satisfactory FDA inspection of a manufacturing facility in Puerto Rico;
- Several post-marketing commitments, including submission of long-term relapse prevention, low dose and pediatric studies
- Additional clarity around the Company’s product education plan for physicians and patients;
- Confirmation by FDA of the acceptability of the product name
While no new studies are required pre-approval, there are post-approval studies to which the company will have to commit in order to gain approval. The FDA currently has no authority to enforce post-marketing studies.
The studies outlined are certainly admirable, but it is interesting to note the length to which the FDA is asking for specific studies in post-marketing commitments – from long-term use to pediatric studies. Should the agency actually get such authority from this reform-minded Congress, it will be interesting to see how these commitments are enforced and this approvable letter serves as insight on how the agency might approach the issue.
The list of approvable letters in the column to the left will be updated this weekend.