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August 2006
August 9
Cephalon Receives Non-Approvable Letter on Sparlon
August 11
Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
August 18
Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant
August 22
FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder
August 24
Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge
Shire Announces NDA Submission of Guanfacine Extended Release for the Treatment of ADHD in Children and Adolescents
August 28
Epix Pharmaceuticals Receives Response from the FDA Regarding Appeal of Vasovist Approvable Letters
InSite Vision Announces FDA Acceptance of New Drug Application for Review
August 29
Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate
FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth
August 30
FDA Accepts for Review NDA Filing for Zensana (Ondansetron HCl) Oral Spray
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