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Generic Cyclessa Receives FDA Nod

WOODCLIFF LAKE, N.J., Feb. 25 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its wholly-owned subsidiary, Barr Laboratories, Inc., received approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market a generic version of Organon's Cyclessa(R) (desogestrel/ethinyl estradiol) Tablets oral contraceptive. The Company expects to be the first to market generic Cyclessa and is launching the product immediately. The Company plans to market the product as a branded generic using the Velivet(TM) trademark.

Velivet (desogestrel/ethinyl estradiol) Tablets are a triphasic oral contraceptive product, containing a combination of a progestin and estrogen, the two kinds of female hormones. Each beige tablet contains 0.100 mg desogestrel and 0.025 mg ethinyl estradiol; each orange tablet contains 0.125 mg desogestrel and 0.025 mg ethinyl estradiol; and each pink tablet contains 0.150 mg desogestrel and 0.025 mg ethinyl estradiol. Each white tablet contains inert ingredients. Velivet is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception and is supplied in a 28-day regimen.

Velivet will compete in a market that had annual sales of approximately $22.5 million for the twelve months ending December 2003, based on IMS data.

Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Source: Barr Pharmaceuticals, Inc.

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