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Dr. Reddy's files ANDA with USFDA

HYDERABAD: Dr. Reddy's Laboratories has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA for Ondansetron Hydrochloride tablets equivalent to 16mg base, with a para IV certification on the four orange book patents. This dosage is not being marketed by GlaxoSmithKline. Dr.Reddy's said it notified GlaxomSmithkline, upon which the latter filed a lawsuit against the company in the U.S. New Jersey District Court, alleging infringement on three of the four Orange Book Patents, as also a process patent not listed in the Orange Book.

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