The United States Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application for United States-based Impax Laboratories, Incorporated's (NASDAQ: IPXL) generic version of Renvela® (sevelamer carbonate) tablets, 800 mg, it was reported on Monday.
The company has immediately started commercialisation activities and says that sales of generic Renvela are likely to benefit its financial results this year and had been reflected in its earlier announced earnings guidance of USD0.55 to USD0.70 per diluted share for fiscal year 2017.
Paul Bisaro, president and chief executive officer of Impax, stated: "We are pleased to receive approval of our generic version of Renvela. The immediate launch of this product further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option."
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