Bayer receives FDA approval for lower dose formulation of ANGELIQ

Feb 29 2012

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a lower dose formulation of ANGELIQ^®  (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus.  The new formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2) and will be available in the U.S. by prescription shortly.

The previously approved prescription formulation of ANGELIQ contains 0.5 mg drsp/1 mg E2 and is indicated for the treatment of moderate to severe vasomotor symptoms and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause in women who have a uterus.

"We are pleased by the approval of this important new lower dose option for menopausal women," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "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."  

SOURCE Bayer HealthCare Pharmaceuticals Inc.