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Ranbaxy gets US FDA nod for generic Pravachol
By siliconindia
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Friday, 03 October 2003, 19:30 IST |
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MUMBAI: Ranbaxy Laboratories said on Friday that it had received tentative approval from the US Food and Drug Administration (FDA) for selling its generic form of Bristol-Myers Squibb's cholesterol-reducing Pravachol.
Pravachol is one of a widely used class of cholesterol fighters known as statins and its competitors in the $15 billion market include Pfizer Inc's Lipitor and Merck & Co Inc's Zocor.
Ranbaxy, India's largest drugmaker by sales, said annual sales in the pravastatin tablet market in the year ended June 2003 totalled $1.8 billion.
It has got the approval for manufacturing pravastatin sodium tablets in the 10 mg, 20 mg, 40 mg, and 80 mg strengths, on the heels of an approval for its Zocor generic.
Ranbaxy said on Monday it had received the go-ahead from the US FDA for simvastatin tablets.
Lek Pharmaceuticals, Geneva Pharmaceuticals, IVAX Pharmaceuticals and Teva Pharmaceuticals have already received a tentative nod from the US FDA for pravastatin tablets.
Analysts expect Bristol-Myers to lose its patent protection on Pravachol in 2006.
Ranbaxy said Friday's approval was its 20th Abbreviated New Drug Application approval in 2003.