Wyeth’s Pristiq antidepressant received conditional FDA approval, delayed by the agency due to problems at the drug’s manufacturing site in Guayama, Puerto Rico.
The manufacturing site is awaiting final inspection by the FDA, however no firm timetable has been issued.
“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,” Joseph Mahady, president of the company’s Wyeth Pharmaceuticals Unit said in a statement.
An FDA spokeswoman said in published reports that the agency “doesn’t provide information on pending inspections.”
Concerns about quality control at Wyeth’s Guayama plant also arose in May after the FDA criticized the company for lapses involving at least a dozen drugs manufactured there. In 2000, Wyeth recalled more than 4 million capsules of generic painkiller Lodine made at the same Guayama plant.
Wyeth is hoping that Pristiq will be able to replace Effexor, the world’s top-selling antidepressant with $3.5 billion in 2005 sales. Effexor loses patent protection in 2010. Wyeth said Pristiq may generate $2 billion annually if approved as an antidepressant and a menopause treatment, a secondary use the FDA may rule on in April.