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Concerned that the positive trials might have occurred by chance and the amount of countervailing evidence, the FDA rejected the New Drug Application from the sponsor 4 times (Organon in 1999, 2002, and 2004, and Fabre-Kramer Pharmaceuticals, Inc in 2007)

(a) the Unapproved Compounded Drugs are compounded drugs that have not been approved by the FDA

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Bacteriostatic water is sterile water containing 0.9% benzyl alcohol, which acts as a bacteriostatic preservative that helps inhibit bacterial growth

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