Impax loratadine approval
This article was originally published in The Tan Sheet
Executive Summary
Hayward, Calif.-based firm's ANDA for loratadine/pseudoephedrine sulfate 10 mg/240 mg (equivalent to Schering-Plough's Claritin D-24) was approved by FDA, Impax announces March 5. The firm already is authorized to manufacture equivalents to Claritin D-12 and the orally disintegrating Claritin Reditabs. Impax will supply the D-24 equivalent to Wyeth Consumer Healthcare for marketing, mostly likely under the Alavert brand. Wyeth has announced plans for a "complete range" of loratadine products in the Alavert line (1"The Tan Sheet" July 28, 2003, p. 11)...