New Delhi: Mumbai-based pharmaceutical firm Sun Pharma today 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 20mg 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 is estimated at $2.3 billion.
Pantoprazole is indicated for short-term treatment of erosive oesophagitis and hypersecretory conditions.
The company’s stock was trading at Rs1,012, up 0.89% from the last close of Rs1,003.10.