Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. FDA approval on its ANDA for a generic version of Renvela® (sevelamer carbonate) tablets, 800 mg. Impax has immediately initiated commercialization activities.
“We are pleased to receive approval of our generic version of Renvela,” said Paul Bisaro, President and Chief Executive Officer of Impax. “The immediate launch of this product further enhances our generic portfolio and our commitment to provide patients with a more affordable treatment option.”
Sales of generic Renvela are expected to benefit the Company’s financial results this year and had been reflected in its previously announced earnings guidance of $0.55 to $0.70 per diluted share for fiscal year 2017.
Sevelamer carbonate tablets had U.S. brand and generic sales of approximately $1.9 billion, according to IMS Health for the 12 months ending August 2017.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments.
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