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.
GSK wins European Commission approval for Shingrix prefilled syringe
Tri-City Cardiology adds new members to care team
GENinCode expands Mexico presence with CARDIO inCode-Score distribution agreement
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
InsiteOne agrees strategic partnerships with ASCEND Cardiovascular and Apollo Enterprise Imaging
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
LivaNova secures higher Medicare reimbursement for VNS Therapy procedures