FDA approves lower dose of Bayer's Angeliq
WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.
Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.
"We are pleased by the approval of this important new lower-dose option for menopausal women," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "The availability of the new lower dose of Angeliq supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose."