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news.Lupin Pharmaceuticals has said the FDA has granted tentative approval for its abbreviated new drug application for trandolapril tablets, 1mg, 2mg and 4mg.
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Final approval is expected upon expiry of patent protection for the brand product on June 12, 2007.
Upon final approval, Lupin’s trandolapril tablets will be the AB-rated generic equivalent of Abbott’s Mavik tablets, indicated for the treatment of hypertension. The brand product had annual sales of approximately $53 million for the twelve months ended July 2006, based on IMS sales data.
Lupin Pharmaceuticals is the US subsidiary of Bombay, India-based Lupin Ltd.