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news.Impax Laboratories has started shipment of authorized generic Renvela (sevelamer carbonate 800mg tablets), through its generics division Global Pharmaceuticals.
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The drug is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
As part of a settlement agreement, Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets effective immediately.
Impax continues to pursue approval of its pending Abbreviated new drug application (NDA) for generic Renvela with the US Food and Drug Administration (FDA).
Global Pharmaceuticals president Carole Ben-Maimon said the company is excited to market this product and provide patients with a more affordable treatment option.
"This product will be an important contributor to our 2014 financial results," Ben-Maimon said.
Impax is a technology based specialty pharmaceutical firm applying its formulation expertise and drug delivery technology in the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products.