Industry News (HRT)

Novo Nordisk Submits New Drug Application for Women's Health Care Product

Published in Women's Health Weekly, November 17th, 1997

Novo Nordisk A/S has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of a continuous combined hormone replacement therapy (HRT) product for the treatment of symptoms associated with menopause.

The Novo Nordisk product is a combination of 17-beta estradiol, a plant-derived estrogen, and norethindrone acetate in a single tablet. The product was submitted for European approval in September 1997.

Novo Nordisk was the first company to introduce continuous combined HRT with another product, Kliogest^R, which is available in Europe, Asia, Australia, and other parts of the world.

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Source: Women's Health Weekly (1997-11-17)

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