FDA clears Wyeth’s Puerto Rico plant to resume production

Wyeth said today the Food and Drug Administration has given it the green light to resume production at its Puerto Rico plant, where manufacturing troubles have delayed marketing of several drugs.

The news is helping lift the drug-maker's shares on Wall Street. Its shares were up as high as $57.59, up 69 cents or more than 1 percent.

The FDA first issued warning letters to Wyeth about the plant in Guayama, Puerto Rico, in May 2006, saying, among other things, that traces of some drugs were found in bottles of other drugs.

Wyeth, in part, blamed poor communication with the FDA about its remediation efforts and has made management changes at the plant.

Both the FDA and Wyeth have said the problems never posed a health threat to users of Wyeth products. No Wyeth products were recalled.

In its statement, Wyeth said the FDA now has "re-classified" the plant, meaning inspectors have certified that problems they had found were corrected or do not merit further action.

Bernard Poussot, Wyeth's president and chief operating officer, said the FDA re-classification now "allows for the timely approval of new products manufactured at the site."

The products whose approvals or production were delayed by the manufacturing problems included a new contraceptive pill Lybrel, a new post-menopausal osteoporosis drug Viviant, and a new antidepressant Pristiq.

The company did not specify when shipments from the plant might resume. Its statement said only: "Guayama will continue to serve as a strategic manufacturing site and a source for future Wyeth products."

Wyeth's pharmaceutical division is based in Collegeville. The company is headquartered in Madison, N.J.