Cangene's Chickenpox product granted orphan drug designation
Cangene Corporation announced that its varicella zoster immune globulin (VariZIG(TM)) has received Orphan Drug Designation from the United States food and Drug Administration for passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella. This designation will give the drug seven years of market exclusivity after marketing approval is obtained. It also means certain regulatory filing fees will be waived.
"This designation is another step in our commitment to address the unmet medical need faced by susceptible individuals who are exposed to chickenpox. It builds on the expanded access investigational new drug protocol that was approved in January by the FDA," said Dr. John Langstaff, Cangene's president and chief executive officer.
VariZIG(TM) is a purified antibody preparation (hyperimmune) specific for Varicella zoster virus, which causes chickenpox and shingles.
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