Duavee conjugated estrogens/bazedoxifene regulatory update

Pfizer and partner Ligand said FDA approved an NDA for 0.45 mg/20 mg Duavee conjugated estrogens/bazedoxifene (CE/BZA) to treat moderate to severe vasomotor symptoms (VMS) associated with menopause in non-hysterectomized women and to prevent postmenopausal osteoporosis. FDA also issued a complete response letter for 0.625 mg/20 mg Duavee to treat vulvar and vaginal atrophy (VVA). The pharma declined to disclose details. Pfizer said this is the first approval for Duavee and expects a U.S. launch in 1Q14. Ligand said the approval triggered a $425,000 milestone payment from Pfizer under a 1994 deal. ...