The Applicant filed this NDA under

The Applicant filed this NDA under 505(b)(2) pathway for marketing Calclum Gluconate Injection intended for the acute treatment of symptomatic hypocalcemia.The Applicant currently markets Calcium Gluconate Injection, as an unapproved drug and did not provide human exposure information of their unapproved drug. Safety findings noted in literature on the use of calcium gluconate 10% administered intravenously include increased BP, hypercalcemia, nausea or faintness unless given slowly over 5 to 8 minutes, increased urine excretion, increased parathyroid gland sensitivity, increased serum calcitonin levels, transient flush sensation that lasted for one minute, severe cardiac arrhythmias when administered as a bolus dose, calcinosis cutis, calcifications in vessel walls and eccrine sweat glands, localized skin necrosis was observed in 4 cases, local tissue necrosis, calcification of kidney. Most of these are from case reports, and the source of calcium gluconate used is unknown.