Bayer HealthCare Pharmaceuticals has received FDA approval for a lower dose formulation of ANGELIQ (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women.
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The product, which contains 0.25mg drospirenone (drsp)/0.5mg estradiol (E2), will be available in the US by prescription shortly, the company said.
The new formulation significantly reduces the occurrence of moderate to severe vasomotor symptoms, such as hot flashes and night sweats, generally within four weeks of therapy initiation.
Bayer US Medical Affairs vice president and head 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.
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