The limitation of the technologies of the past forced the use of limited-size samples and approximation methods.

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If you use the safe harbor option, any unused expense caused by the above limitation cannot be carried forward.

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In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer, is likely to get similar labeling.

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In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer (nyse: PFE - news - people ), is likely to get similar labeling.

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