Another US approval delay for Pfizer's Fablyn

World drug giant Pfizer has received a complete response letter from the US Food and Drug Administration asking for additional information on  lasofoxifene, which is under review for the treatment osteoporosis in  postmenopausal women at increased risk of fracture.

Pfizer says it is reviewing the letter and will work with the agency to  determine the appropriate next steps regarding the company's  application. Last year, an FDA scientific advisory panel voted nine to  three (with one abstention) that there is a population of postmenopausal  women with osteoporosis in which the benefits of lasofoxifene likely  outweigh the risks (Marketletter September 15, 2008).

The Committee for Medicinal Products for Human Use (CHMP) of the  European Medicines Agency (EMEA) issued a positive opinion on December  18, 2008, recommending marketing authorization for lasofoxifene.