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ANDA approvals

This article was originally published in The Tan Sheet

Executive Summary

Alpharma receives FDA clearance for private label permethrin lotion 1% (ANDA 75-014) on March 28. The product is the first approved generic version of Warner-Lambert's Nix pediculicide, the company says. Alpharma plans to launch the private label product April 1 in 60 mL bottles in single-, double- and triple-packs. Pfizer's Rid, which contains pyrethrum extract, was extended with a mousse delivery form approved March 7 under an "NDA Deviation" (1"The Tan Sheet" March 13, p. 4). Cheminor also receive ANDA approval March 28 for a generic version of a Warner product. The company's ranitidine 75 mg tablets (ANDA 75-294) will compete with the W-L reference drug, Zantac 75; the H2 antagonist lost its marketing exclusivity last June

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