CMP Pharma's Potassium Phosphates Injection Receives FDA Shelf Life Extension for Specific Lots

2023-03-31

上市批准

FARMVILLE, N.C., March 31, 2023 /PRNewswire/ -- CMP Pharma, Inc. announced today that in order to mitigate drug shortage concerns, the FDA's CDER Office of Compliance has granted a shelf life extension for CMP Development LLC Potassium Phosphates Injection (NDA 212121). Providers and patients that have the lot numbers listed below in stock will now be able to use supply through the corresponding new use dates. CMP PHARMA Potassium phosphates injection (phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 71 mEq/15 mL (4.7 mEq/mL)) This regulatory discretion by the FDA does not extend beyond the lots listed above which have now been listed on the FDA Drug Shortage webpage: CMP Pharma's Potassium Phosphates Injection is appropriate for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg. Other formulations are in shortage again which is a recurring problem. CMP consistently has supply of potassium phosphates available for you and your patient's needs. CMP Pharma's FDA-approved Potassium Phosphates Injection can be ordered using NDC 46287-024-10 (10 X 15 mL single-dose glass vial). For more information, contact CMP Pharma at 252-753-7111. About CMP Pharma, Inc. CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including oral liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE POTASSIUM PHOSPHATES INJECTION is a phosphorus replacement product indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated. Limitations of Use: Safety has not been established for parenteral nutrition in adults weighing less than 45 kg or pediatric patients less than 12 years of age or weighing less than 40 kg due to the risk of aluminum toxicity. CONTRAINDICATIONS hyperkalemia hyperphosphatemia hypercalcemia or significant hypocalcemia severe renal impairment (eGFR less than 30 mL/min/1.73m2) and end stage renal disease WARNINGS AND PRECAUTIONS Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration: Administer only after dilution or admixing; do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. Hyperkalemia: Increased risk in patients with renal impairment, severe adrenal insufficiency, or treated with drugs that increase potassium. Patients with cardiac disease may be more susceptible. Do not exceed the maximum daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion. Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion. Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. Hypomagnesemia: Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. Vein Damage and Thrombosis: Infuse concentrated or hypertonic solutions through a central catheter. DRUG INTERACTIONS Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations. DOSAGE AND ADMINISTRATION Administer intravenously only after dilution or admixing in a larger volume of fluid. POTASSIUM PHOSPHATES INJECTION provides phosphorus 3 mmol/mL (potassium 4.7 mEq/mL). Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. See full prescribing information for instructions on preparation and administration. ADVERSE REACTIONS Adverse reactions are hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma at 1-844-321-1443 or FDA at 1-800-FDA-1088 or . To view full Prescribing Information please visit: PPH-00035 03/23