Firm said it received an approvable letter for its oral sustained release potassium supplement (10 or 20 mEq). Key calls the delivery technology "microburst," and says it allows the K-Dur tablet "to disperse rapidly into minute, sustained action particles, minimizing localized concentration of the drug in the gastrointestinal tract".
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“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”