Hope Pharmaceuticals today announced that the FDA approved Hope’s Sodium Nitrite Injection for sequential use with sodium thiosulfate for the treatment of cyanide poisoning that is judged to be life-threatening.
Hope is the only supplier of Sodium Nitrite Injection that has been approved by the FDA.
Drugs containing sodium nitrite have been marketed in the United States without FDA approval and reportedly conform to an industry specification originally published prior to 1970 that lists only five tests.
FDA requires new drugs to meet more stringent quality requirements.
The new FDA quality specification for sodium nitrite lists 27 tests, including many recent quality advancements such as limits on bacterial, chemical, degradation, and processing impurities. To comply with the new FDA-imposed requirements, Hope utilizes custom-manufactured, ultra-pure sodium nitrite as the ingredient in its FDA-approved medication.
“Critically-ill patients should receive only high quality medications,” said Dr. Craig Sherman, Medical Director of Hope Pharmaceuticals. “Doctors should consider quality when choosing products from different manufacturers and choose an FDA-approved product whenever one is available. For the first time, doctors can choose to use an FDA-approved Sodium Nitrite Injection that complies with 2012 quality standards.” Hope’s Sodium Nitrite Injection (NDC 60267-311-10) is packaged in a 10 mL vial containing 300 mg of sodium nitrite. It is now available in a carton containing one vial or in an FDA-approved kit (Nithiodote5/8 NDC 60267-812-00) which also contains a vial of Sodium Thiosulfate Injection.
