Four firms get tamoxifen marketing OK

WASHINGTON (CBS.MW) — Marketing efforts will begin immediately by the four companies granted final U.S. regulatory approval to make and sell the generic equivalent of AstraZeneca’s Nolvadex, a widely used treatment for breast cancer.

AstraZeneca’s marketing exclusivity for Nolvadex expired Thursday, opening the way for lower prices for women taking tamoxifen as new competitors enter the market. Sales of branded and generic tamoxifen citrate totaled about $500 million in the U.S. last year.

The Food and Drug Administration cleared the four companies — Ivax
Barr Laboratories
Mylan Laboratories
and Israel-based Teva Pharmaceutical Industries
— to market tamoxifen citrate tablets in strengths of 10 and 20 milligrams.

Shares of Ivax Corp. paced gains Friday, rising rose 5.3 percent in midday action, adding 58 cents to $11.54. Teva gained 51 cents, or 1.4 percent, to $37.62 and Mylan tacked on 21 cents, or 0.8 percent, to $27.72.

Barr lost 13 cents, or 0.2 percent, to $75.95.

AstraZeneca previously supplied tamoxifen tablets to Barr under a non-exclusive agreement in which the Pomona, N.Y.-based company sold them under the Barr label.

Shares of London-based AstraZeneca
added 1 percent, rising 33 cents to $34.77.

The four companies will be taking on a drug that’s been one of the most widely prescribed therapies for breast cancer in the world. A predecessor company of AstraZeneca introduced Nolvadex in 1978.

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The drug works by blocking estrogen in breast tissue, and has also shown effectiveness when cancer has spread to other parts of the body.

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