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Executive Summary

AMERICAN THERAPEUTICS' DANAZOL IS FIRST GENERIC VERSION of Sterling's Danocrine to be approved by FDA. American Therapeutics received approval to market danazol 200 mg capsules on Dec. 30 and launched the product the week of Jan. 4. American Therapeutics' price to wholesalers for the synthetic androgen product is approximately $102 for bottles of 100 capsules. American Therapeutics estimates that Sterling's annual U.S. sales of Danocrine are in the $30 mil. range, and said it hopes to do $6 mil. a year in sales of the generic. Sterling markets Danocrine in 200, 100 and 50 mg capsules. Danazol is one of three first generic approvals issued by FDA in the last week of December. The agency also approved the first generic versions of Upjohn's Cytosar-U (cytarabine) and Ciba-Geigy's Ludiomil (maprotiline HC1). Bolar received approval to market maprotiline HC1 25, 50 and 75 mg tablets on Dec. 30. The generic maprotiline HC1 tablets were made available immediately after the ANDAs were approved. Bolar estimates the market for Ciba-Geigy's Ludiomil to be $25 mil. annually. The generic company expects that its maprotiline will have $1-2 mil. in annual sales. Quad shipments of cytarabine, approved Dec. 30, began on New Year's Eve. Quad's list prices to wholesalers for the anticancer agent are $5.10 for a single-dose 100 mg vial and $20.30 for a multi-dose 500 mg vial.

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