The approvable letter indicated that before the new drug application can be cleared the FDA must receive and analyze final safety and efficacy data from the recently completed phase III treatment study of bazedoxifene.
In addition the FDA said it still has to complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene. The FDA concluded its general re-inspection of Wyeth’s Guayama facility in early April.
“We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches,” said the FDA.
Osteoporosis therapies available generally fall into one of three categories: postmenopausal hormone therapy, bisphosphonates and SERMs. Bazedoxifene is a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.