Sun Pharma gets US nod for pantropazole
The approval for pantoprazole tablets, generic version of Wyeth's Protonix, is for multiple strengths of 20 mg and 40 mg.
By PTI |
NEW DELHI: Mumbai-based pharmaceutical firm Sun Pharma on Tuesday said it has received final approval from the USFDA for the abbreviated new drug application (ANDA) of pantoprazole tablets, used for treating oesophagus ailments.
The approval for pantoprazole tablets, generic version of Wyeth's Protonix, is for multiple strengths of 20 mg and 40 mg, the company said in a statement.
"Sun Pharma being one of the first-to-file an ANDA for generic Protonix with a para IV certificate, shares a 180-day
marketing exclusivity," it added.
"The company is currently evaluating its launch options," it added.
Annual sales of the two strengths of Protonix in the US market is estimated at 2.3 billion dollar.
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Pantoprazole is indicated for short-term treatment of erosive oesophagitis and hypersecretory conditions. The company's scrips were trading at Rs 1,012, up 0.89 per cent from yesterday's close Rs 1,003.10.
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