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Taro gets generic Zyrtec go-ahead

This article was originally published in The Tan Sheet

Executive Summary

FDA approves the Hawthorne, N.Y.-based company's abbreviated new drug application for 5-mg and 10-mg cetirizine hydrochloride tablets. Taro Pharmaceuticals said July 27 it previously received approval for an equivalent of Johnson & Johnson/McNeil's Children's Zyrtec Oral Solution (1"The Tan Sheet" April 28, 2008, In Brief). FDA has already approved private-label versions of the OTC allergy drug manufactured by Perrigo, Sandoz, Ranbaxy and Mylan

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Sun Pharma buys controls of Taro

The Indian firm acquires a majority stake in Taro Pharmaceutical Industries for $144 million - substantially less than its initial offer of $434 million for 100 percent of the firm three years ago. Sun Chairman and Managing Director Dilip Shanghvi takes over as chairman of Taro, which distributes primarily in Israel, Canada and the U.S. Taro's reported net sales reached $360.5 million in 2009. Sun has 48.7 percent economic interest in Taro and 65.8 percent voting rights on management decisions. Taro owner Barrie Levitt maintains a 12 percent stake, but has 41 percent voting rights. Sun Director Sudhir Valia is vice chair of Taro, and his son, Aalok Shanghvi, and Sun Director Hasmukh Shah were appointed directors. FDA has approved Taro private label equivalents of branded OTCs including McNeil Consumer Healthcare's Zyrtec allergy drug (1"The Tan Sheet" Aug. 10, 2009, In Brief)

FDA approves more children’s Zyrtec equivalents

Taro Pharmaceuticals Industries receives FDA approval for its children's cetirizine hydrochloride oral solution 1 mg/mL preparation, the Hawthorne, N.Y.-based firm announces April 22. The product is equivalent to McNeil Consumer Healthcare's Children's Zyrtec Oral Solution. Citing industry sources, Taro says the allergy treatment generated annual U.S. sales of $160 million when it was available only by prescription. Indian drug firm Ranbaxy and Canadian generics manufacturer Apotex also recently received approval for private-label children's cetirizine. Allegan, Mich.-based private labeler Perrigo received approval for its children's Zyrtec equivalent April 9 and also markets generic versions of both adult-indicated Zyrtec products, original Zyrtec (cetirizine 5 mg) and Zyrtec-D extended-release tablets (cetirizine 5 mg/pseudoephedrine 120 mg) (1"The Tan Sheet" April 14, 2008, In Brief)...

Drug Pricing ‘Not Appropriate Topic’ For WTO TRIPS Council

The World Trade Organization is not the place to discuss pharmaceutical pricing, and strong intellectual property rights do not threaten access to medicines, according to EU and US delegations to the WTO.

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