Medicure announced the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Sodium Nitroprusside Injection 50 mg/2 mL (25 mg/mL) single dose vial (SNP), a generic intravenous cardiovascular drug product. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure. Refer to Important Safety Information below. Medicure's newly approved product was determined by the FDA to be therapeutically equivalent to Nitropress (Sodium Nitroprusside Injection). The filing of the ANDA was previously announced by the company on December 13, 2016.
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"Medicure is pleased to add SNP to its cardiovascular commercial operation. This generic cardiovascular drug fits well with Medicure's mission of being a significant, value based, cardiovascular pharmaceutical company focused on the U.S. market." said the Company's President and CEO, Dr. Albert D. Friesen.