ziconotide acetate

FDA Drug Profile — PRIALT

ziconotide acetate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including PRIALT. Available dosage form: injection, solution.

Drug Details

Generic Name
ziconotide acetate
Brand Names
PRIALT
Application Number
NDA021060
Sponsor
TerSera Therapeutics LLC
NDC Codes
6
Dosage Forms
INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients
ZICONOTIDE ACETATE

Indications and Usage

1 INDICATIONS AND USAGE PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. PRIALT (ziconotide) solution, intrathecal infusion is an N-type calcium channel antagonist indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. ( 1 )