FDA In Tug-Of-War Over Generic Cozaar/Hyzaar: Apotex And Roxane Sue Agency To Block Teva's Marketing Exclusivity
FDA is engaged in a heated legal battle with Apotex and Roxane over its decision to grant Teva 180-day marketing exclusivity for generic versions of Merck's hypertension drugs Cozaar (losartan) and Hyzaar (losartan/hydrochlorothiazide)
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The agency says it has no choice but to award Teva exclusivity given an appeals court decision limiting forfeiture; Apotex has not decided whether it will challenge the court's ruling.
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