US FDA gives Final Nod to Sun Pharma’s Pantropazole Tabs

Sun Pharma
New Delhi: Finally, Sun Pharma has got approval from the USFDA for its abbreviated new drug application (ANDA) of pantoprazole tabs, for treating oesophagus disorders.

In a statement, the company said the commendation for pantoprazole tabs, generic edition of Wyeth’s Protonix, is for multiple potencies of 20mg and 40 mg.

“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,” the statement added.

“The company is currently evaluating its launch options,” it also said.

Yearly sales of the two strengths of Protonix in the US market stood at 2.3 billion dollar.

Pantoprazole is indicated for treating erosive oesophagitis and hypersecretory conditions temporarily.

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