Although Botox and RT002 both have type-A botulinum toxin as their active ingredient, they are not therapeutic equivalents, and RT002 will never face generic competition. Hence, the FDA’s Orphan Drug Designation for RT002 in cervical dystonia has minimal practical consequence aside from saving RVNC a little money on FDA application fees.
BTW, all commercial botulinum-toxin products of consequence are type-A toxins. Myobloc (originally developed by Elan and marketed by Solstice Neurosciences) is a type-B toxin, but its sales are negligible.
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