The company already markets three smaller dosages of the heart disease treatment.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained final US Food and Drug Administration (FDA) approval for Pravastatin Sodium tablets, the generic version of Bristol-Myers Squibb’s (NYSE: BMY) Pravachol for the treatment of certain hyperlipidemias and the primary prevention of coronary events.
The FDA approved Teva's Abbreviated New Drug Application (ANDA) for 80 mg tablets of generic Pravachol. Teva is already marketing10 mg, 20 mg and 40 mg dosages of Pravastatin Sodium. According to IMS data, brand and generic sales in the US of 80 mg Pravastatin Sodium totaled $173 million in the 12 months through September 2007.
Published by Globes [online], Israel business news - www.globes-online.com - on January 20, 2008
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