Wyeth conditionally approved for osteoporosis drug
(Adds conditions, company comment, analyst forecast, share price)
NEW YORK, April 24 (Reuters) - Wyeth WYE.N said on Tuesday it was informed by U.S. health regulators that its experimental osteoporosis drug, bazedoxifene, will be approved if certain conditions are met.
The company said last week it was expecting conditional approval from the Food and Drug Administration for the medicine, to be called Viviant, for the prevention of post-menopausal osteoporosis.
Wyeth said it was also moving forward with plans to seek U.S. approval of the drug for the treatment of post-menopausal osteoporosis later this year.
The conditions for approval in the so-called approvable letter sent by the FDA included an FDA evaluation of the manufacturing and testing facilities for the drug and an FDA analysis of final safety and efficacy data from the recently completed pivotal clinical studies of the medicine, Wyeth said.
The FDA concluded a general reinspection of Wyeth's manufacturing plant in Guayama, Puerto Rico in early April, and Wyeth said it had provided a written response to the FDA's observations.
The company said it believes the situation at the Guayama facility will be resolved without affecting the timing of new product launches.
"The approvable letter for bazedoxifene is in line with our expectations, and we are pleased to stay on track with our plans to introduce this new osteoporosis therapy," Gary Stiles, chief medical officer for Wyeth Pharmaceuticals said in a statement.
Cowen & Co. analysts earlier this year had estimated Viviant sales of $250 million by 2012.
Wyeth shares closed down 20 cents to $55.53 on the New York Stock Exchange.
((Reporting by Bill Berkrot, editing by J.S. Benkoe; Reuters Messaging: email@example.com phone 646 223-6030)) Keywords: WYETH OSTEOPOROSIS/
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