Teva gets tentative FDA OK for generic Lotrel
Israeli drugmaker Teva Pharmaceutical Industries says that the US Food and Drug Administration has tentatively approved its Abbreviated New Drug Application in relation to the marketing of a generic version of Novartis' hypertension treatment Lotrel (amlodipine besylate and benazepril HCL).
The company added that it is still involved in a patent litigation suit in the US District Court in New Jersey, which was filed against it in 2004, regarding its paragraph IV certification of US patent number 6,162,802. A trial date has not yet been set.
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