Specialty pharmaceutical company Impax, which develops both generic and branded drug products, announced in April 2017 that it has received FDA approval for a generic version of Vytorin (ezetimibe/simvastatin).

The drug, which is marketed by Merck & Co in the US, is used to treat high levels of lipids in the blood and comprises a combination of a cholesterol lowering drug (ezetimibe, marketed as Zetia) and a statin (simvastatin, marketed as Zocor). Vytorin tablets brought in sales of over US$670 million in the US for the year ending February 2017, according to IMS Health.

Impax received approval for four dosage forms (10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg) and has already begun commercialization. CEO Paul Bisaro said that Impax ‘are pleased to be one of the first companies to offer a generic version of Vytorin and provide patients with an affordable treatment option’. He also commented that the approval demonstrates Impax’s ability to develop, manufacture and market generic drugs.

Indeed, Impax is making headway in the generics market. In 2015, they received approval for a generic version of the ADHD drug Intuniv (guanfacine) [1]. The company recently acquired Tower Holdings, which has also helped to expand its generics portfolio [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. ADHD generic receives US FDA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 26]. Available from: www.gabionline.net/Generics/News/ADHD-generic-receives-US-FDA-approval
2. GaBI Online - Generics and Biosimilars Initiative. Anticompetitive acquisition forces generics sale [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 26]. Available from: www.gabionline.net/Pharma-News/Anticompetitive-acquisition-forces-generics-sale

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