Wyeth said Friday that U.S. regulators have again denied approval of the drug maker’s osteoporosis drug bazedoxifene requesting additional information on stroke and blood clot issues.
Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
Following the introduction of HAART (Highly Active Antiretroviral Therapy), the survival and quality of life for people infected with the human immunodeficiency virus (HIV-1) have increased in the resource-rich countries. However, with this improved prognosis an increase in long term negative disorders has been observed, namely osteoporosis (the gradual loss of bone mass). Osteoporosis is a …