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Wyeth "fast dissolving" Ativan

Executive Summary

Firm petitioning FDA to allow ANDA approval route for fast-dissolving formulations of its currently marketed 0.5 mg, 1 and, 2 mg lorazepam tabs. Freeze-dried tab is "designed to dissolve rapidly in the mouth upon contact with saliva" to improve compliance in patients who have difficulty swallowing conventional tabs, Wyeth told FDA in an Oct. 30 petition.
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PS009287

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