An abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Vytorin has been filed by Impax with the US Food and Drug Administration (FDA).
Schering and MSP Singapore have filed suit for patent infringement against Impax in the US District Court for the District of New Jersey, on 19 August 2010.
Vytorin (ezetimibe and simvastatin) is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia, as well as toreduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipidlowering treatments.
Impax's generic division, Global Pharmaceuticals, is expected to launch the products after final ANDA approval.
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