Therapy Areas: Cardiovascular
US FDA Approves Acute Care Cardiovascular Drug Sodium Nitroprusside Injection
16 August 2018 - - The United States Food and Drug Administration has approved Canadian cardiovascular pharmaceutical company Medicure Inc.'s (TSX Venture: MPH) (OTC: MCUJF) Abbreviated New Drug Application for Sodium Nitroprusside Injection 50 mg/2 mL (25 mg/mL) single dose vial, a generic intravenous cardiovascular drug product, the company said.

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 US market." said the company's president and CEO, Dr. Albert D. Friesen.

Medicure is a pharmaceutical company focused on the development and commercialisation of therapeutics for the US cardiovascular market.

The present focus of the company is the marketing and distribution of AGGRASTAT (tirofiban hydrochloride) injection and Zypitamag (pitavastatin) tablets in the United States, where they are sold through the company's US subsidiary, Medicure Pharma, Inc.
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