Drug Development

FDA grants approval for Enjuvia for vasomotor symptoms

Published in Drug Week, January 28th, 2005

Barr Pharmaceuticals, Inc., (BRL) announced that its subsidiary, Duramed Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval for its New Drug Application (NDA) for Enjuvia (synthetic conjugated estrogens, B) 0.3 mg and 0.45 mg tablets.

The company's NDA for Enjuvia (synthetic conjugated estrogens, B) 0.625 mg and 1.25 mg tablets received FDA approval in May 2004.

The company's Enjuvia product line includes the lowest dose, plant- derived, synthetic conjugated estrogen product approved for the treatment of vasomotor symptoms. Enjuvia tablets contain a blend of 10 synthetic estrogenic substances, including the component...

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Source: Drug Week (2005-01-28)

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