APP Obtains FDA Approval For Sumatriptan Succinate Injection, USP

APP Pharmaceuticals, a wholly-owned subsidiary of Fresenius Kabi Pharmaceuticals (Kabi), has received approval from the FDA to market Sumatriptan Succinate Injection, USP, in two dosage strengths.

Sumatriptan Succinate Injection is a vascular headache suppressant indicated for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.

Reportedly, APP will package Sumatriptan Succinate Injection in pre-filled syringes of 4mg (base)/0.5 ml and 6mg (base)/0.5 ml. In February 2009, APP has received approval for Sumatriptan Succinate for injection, USP packaged in single dose vials of 6mg/0.5 ml.

Thomas Silberg, president and chief executive officer of APP, said: “The launch of this important migraine medication in pre-filled syringes provides APP customers with a full product line of dosages and strengths for generic Sumatriptan.”