The US Food and Drug Administration (FDA) has cleared Hope Pharmaceuticals' Sodium Nitrite Injection for use with sodium thiosulfate for the treatment of cyanide poisoning.
Sodium Nitrite Injection (NDC 60267-311-10) is packaged in a 10mL vial containing 300mg of sodium nitrite.
The sodium nitrite injection is approved for use in children and adults, the company said.
To meet the new FDA-imposed requirements, the company utilizes custom-manufactured, ultra-pure sodium nitrite as the ingredient in its FDA-approved medication.
Hope Pharmaceuticals medical director Craig Sherman said doctors can now use an FDA-approved Sodium Nitrite Injection that complies with 2012 quality standards.
Source:
http://drugdelivery.pharmaceutical-business-review.com/news/fda-clears-hope-sodium-nitrite-injection-130412
