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Abbreviated NDA For Valproate Sodium Injection Approved
SCHAUMBURG, Ill., June 30 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of valproate sodium injection. Valproate sodium injection, the generic equivalent of Abbott Laboratories' Depacon® Sodium Injection, is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
"Valproate represents the fifth product approval APP has received thus far in 2003 and complements our growing critical care offering," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer. "APP has launched three products this year. We also have received tentative approvals for carboplatin and fluconazole, both of which are large market opportunity drugs with combined innovator sales exceeding $700 million in 2002, according to IMS, and whose patents expire in 2004."
Valproate sodium injection is an intravenous alternative in patients for whom oral administration of valproate products is not feasible. Valproate products have a "black box" warning for patients with hepatic disease or significant hepatic dysfunction.