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Impax loratadine approval

This article was originally published in The Tan Sheet

Executive Summary

Generics firm to begin shipments of loratadine 5 mg/pseudoephedrine 120 mg tablets to Schering-Plough, Wyeth "within days" of FDA's Jan. 30 approval of firm's ANDA (76-050). Impax Labs notes it has been manufacturing Claritin-D 12-Hour equivalent since November. Firm says it received "first-to-file" status with 180 days of generic marketing exclusivity triggered by first shipment. Under an agreement announced last June, Impax will manufacture, supply Schering with Claritin-D 12-Hour for OTC sale; product will reach shelves in early 2003, Schering says (1"The Tan Sheet" July 1, 2002, p. 4). Impax also has licensing, supply agreement with Alavert marketer Wyeth...
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