Barr Laboratories Inc announced that the U.S. Food and Drug Administration (FDA) has approved its applications to manufacture and market generic versions of Galen's Loestrin Fe 1/20 and 1.5/30 Tablets, USP, oral contraceptives. The Company plans to market the products as generics under the trademark names Junel Fe 1/20 and Junel Fe 1.5/30. The Company will launch both its Junel Fe products and its Junel 21 1/20 and Junel 21 1.5/30 products, which were approved in late May 2003, immediately.
"With the launch of our Junel oral contraceptive products we continue to solidify Barr's position in the $2.9 billion U.S. oral contraceptive marketplace," said Bruce L. Downey, Barr's Chairman and CEO. "These most recent launches increase our currently marketed generic oral contraceptive product portfolio to 15."
Junel Fe 1/20 is a regimen consisting of 21 oral contraceptive tablets that contain 1 mg of norethindrone acetate and 0.02 mg of ethinyl estradiol, and 7 ferrous fumarate tablets. Junel Fe 1.5/30 is a regimen consisting of 21 oral contraceptive tablets that contain 1.5 mg of norethindrone acetate and 0.03 mg of ethinyl estradiol, and 7 ferrous fumarate tablets. Both products are indicated for the prevention of pregnancy in women who elect to use the product as a method of contraception and are supplied in a 28-day regimen.
Junel Fe 1/20 and Junel Fe 1.5/30 will compete in a market that had combined annual sales of approximately $194 million for the twelve months ending July 2003. Junel 21 1/20 and Junel 21 1.5/30 will compete in a market that had combined annual sales of approximately $19.2 million for the twelve months ending July 2003.