Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection

WINNIPEG, Medicure Inc., a cardiovascular pharmaceutical company, is pleased to announce that 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. The Company continues to develop two additional generic versions of acute cardiovascular drugs and explore other potential development opportunities.

"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." commented the Company's President and CEO, Dr. Albert D. Friesen.

About Medicure

Medicure is a pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection and ZYPITAMAGTM (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.

Sources
  • Medicure Inc.

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