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Sun gets FDA marketing nod for Protonix

Sun Pharmaceutical wins FDA approval for its ANDA to market a generic version of Wyeth's Protonix tablets

India-headquartered generic manufacturer Sun Pharmaceutical has won FDA approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Wyeth's Protonix tablets (pantoprazole).

Pantoprazole is indicated for the short-term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for the treatment of hypersecretory diseases.

Sun's generic pantoprazole tablets are copies of Wyeth's Protonix Delayed Release Tablets and include 20 mg and 40 mg doses, both of which post annual US sales of around USD 2.3bn.

Sun, which was the first-to-file its generic Protonix ANDA with a Paragraph IV certification, also gains a 180-day marketing exclusivity.

Sun stated that it was now mulling its launch options.

30th September 2008

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