Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) said on Friday that the US Food and Drug Administration (FDA) has granted tentative approval for Teva's generic version of Amgen’s Sensipar.
Sensipar is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Teva's abbreviated new drug application was for tablets in 30, 60 & 90 milligram dosages.
According to IMS sales data, branded Sensipar had annual US sales of approximately $458 million.
Teva is currently involved in patent litigation over the drug in the US District Court for the District of Delaware. A trial date has not been set.
Teva shares fell $1.02, or 1.76%, to $56.80 on Friday, giving a market cap of $50.72 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on May 16, 2010
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