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Barr's generic Ortho-Cyclen Tablets approved

POMONA, N.Y., Sept. 25, 2002 -- Barr Laboratories announced that the FDA has approved its application to manufacture and market a generic version of Ortho-McNeil Pharmaceutical's Ortho-Cyclen Tablets oral contraceptive 28-day regimen.

Barr plans to launch the product immediately, as a generic under the trademark name Sprintec.

"Sprintec joins the company's currently marketed generic oral contraceptive portfolio that numbers eight products and competes in the $2.4 billion oral contraceptive marketplace place," said Bruce L. Downey, Barr's Chairman and CEO. "We are pleased to be the first company to receive approval to manufacture and market a generic Ortho-Cyclen product and believe that Sprintec will contribute to the significant growth in our oral contraceptive portfolio.

Ortho-Cyclen is a regimen of oral contraceptives that contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. The brand product is supplied in a 28-day regimen.

Source: Barr Laboratories

Posted: September 2002