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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With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.
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