However, the approval is subject to certain conditions requested by the FDA. Wyeth currently has problems at its manufacturing plant in Guayama, Puerto Rico, where Pristiq will be manufactured. The FDA will conduct an inspection as part of the approval process.
“We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments,” said Joseph Mahady, president, Wyeth Pharmaceuticals, North America and Global Businesses.
The FDA also said it will require a submission of long-term relapse prevention, low dose and pediatric studies and additional clarity around the company's product education plan for physicians and patients, before it will authorize the product for sale.
Final FDA approval of the drug will also rest on the results of ongoing major depressive disorder studies at lower dosage levels, and the progress of Wyeth's separate new drug application for Pristiq in the treatment of vasomotor symptoms associated with menopause.
Wyeth noted that while the approvable letter requires some post-marketing commitments, the FDA does not require that any additional clinical studies be submitted prior to the approval of Pristiq.
Despite these conditions, Wyeth said that it remains on track with its plans for Pristiq. If approved, Pristiq will be the first and only non-hormonal medicine for the treatment of vasomotor symptoms associated with menopause.