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

1 April 2023

CMP Pharma 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: https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages#table

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.

https://cmppharma.com/
https://potassiumphosphates.com/

 

Source:prnewswire.com