Ranbaxy gets tentative FDA nod for ulcer drug

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Posted: Thursday, Feb 07, 2008 at 1402 hrs IST
Updated: Thursday, Feb 07, 2008 at 1420 hrs IST

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Mumbai, February 7: : Drug maker Ranbaxy Laboratories on Thursday said it has received a tentative approval from the US Food and Drug Administration for Esomeprazole Magnesium Delayed-Release capsules in strengths of 20 mg and 40 mg.

Esomeprazole is used in the treatment of erosive esophagitis (inflammation of the esophagus), heartburn and other symptoms associated with ulcer.

Ranbaxy has informed the Bombay Stock Exchange that it has a FTF (First to File) status on the drug, providing it with 180 days marketing exclusivity.

Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of the company, is involved in sale and distribution of generic and branded prescription products in the US healthcare system.

Nexium (Esomeprazole) is the second largest selling drug in the US with total annual market sales of 5.5 billion dollars, the company said.

The shares of the company were trading at Rs 371.10 in afternoon, down 3.20 per cent on the BSE.

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