APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (APCVZ), Thursday said it has received approval from the U.S. Food and Drug Administration, or FDA, to market Sumatriptan Succinate injection, USP, in two dosage strengths of 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL.
Sumatriptan Succinate injection, which is therapeutically equivalent to GlaxoSmithKline plc's (GSK) drug Imitrex, is a vascular headache suppressant indicated for the acute treatment of migraine attacks.
In February 2009, APP Pharma received approval for Sumatriptan Succinate for injection, USP packaged in single dose vials of 6 milligram/0.5 milliliter.
According to IMS Health data, 2008 sales of Sumatriptan Succinate injection in the US were nearly $241 million. Refills and syringe cartridges accounted for over $218 million.
APP Pharma was acquired by Fresenius Kabi Pharmaceuticals in September 2008, and has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico.
APCVZ closed Wednesday's regular trading at $0.53 per share on the Nasdaq.
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