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Description

We proposed at 428.202(e)(4) that for a subsequently approved drug for which there are no quarters during the first calendar year beginning after the drug's first marketed date for which AMP has been reported under the MDRP, the benchmark period CPI-U is the CPI-U for January of the calendar year in which such drug has at least 1 quarter of AMP reported

The use of huperzine A during pregnancy and lactation is not recommended due to the lack of sufficient safety data

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