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Category: FDA Litigation
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We previously reported on Apotex’s lawsuit against the FDA concerning generic Zofran (ondansetron HCl) tablets. Apotex sought an injunction directing FDA to approve Apotex’s ANDA for generic Zofran tablets when GlaxoSmithKline’s pediatric exclusivity on Zofran expired on December 24, 2006. Although Dr. Reddy’s was the first to file an ANDA for generic Zofran tablets, Apotex…
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Apotex filed a complaint and motion for preliminary injunction against the FDA in the U.S. District Court for the District of Columbia last week, alleging that the FDA unlawfully refused to acknowledge that the dismissal of its patent infringement suit against GlaxoSmithKline over generic Zofran was a "court decision" triggering the first ANDA filer’s 180…
