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Home » Ranbaxy Sues FDA Over Nexium & Valcyte ANDA Revocation
Ranbaxy Sues FDA Over Nexium & Valcyte ANDA Revocation
Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations.