Wyeth can now pursue approval of several new drugs and step up the production of others after finally passing inspections at its troubled manufacturing plant in Puerto Rico, the company said yesterday.
The facility in Guayama, also home to other pharmaceutical plants, had been idled for nearly a year while Wyeth responded to regulators and made management changes there.
The situation affected up to a dozen drugs, including Wyeth's top-selling antidepressant, Effexor. It also contributed to delays in Food and Drug Administration approval of Wyeth's contraceptive pill Lybrel, the postmenopausal osteoporosis drug Viviant, the antidepressant Pristiq, and the antipsychotic bifeprunox - all to be made at the plant.
News of the restart boosted the drugmaker's shares in morning trading, but they moderated to close only slightly higher at $56.82, up 18 cents.
Industry analysts anticipating the announcement already had pushed up Wyeth's stock 12 percent since early April.
Wyeth said FDA inspectors now had given the plant a "positive reclassification," meaning problems had been corrected or did not merit further action.
One of the initial problems involved discovery of a screw and washers in a medicine bottle. Wyeth, in part, blamed poor communication with the FDA about its remediation efforts.
Both the FDA and Wyeth have said the problems never posed a health threat to users of Wyeth products.
Bernard Poussot, Wyeth's president and chief operating officer, said the FDA action now "allows for the timely approval of new products manufactured at the site."
The company did not specify when shipments from the plant might resume, or when the FDA might act on Wyeth's new drug applications.
It did reaffirm that "Guayama will continue to serve as a strategic manufacturing site and a source for future Wyeth products."
Besides responding to FDA inspectors, the company has added "several new positions in different functions at the plant," Wyeth said in an e-mail answer to questions.
"Most of our recruiting has been done on the island, and we have also transferred in a few employees from other Wyeth locations," the company said.
Wyeth's pharmaceutical division, which operates the plant, is based in Collegeville. Wyeth's headquarters are in Madison, N.J.
Other products made at the plant include Protonix, Rapamune and Advil, the company said.
In recent years, Wyeth said it also had built new "quality-control labs" at the site and new manufacturing "suites" to support production.