Vytorin generic launched in the US

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Vytorin generic launched in the US

Genéricos/Novedades | Posted 26/05/2017 0 Post your comment

The US Food and Drug Administration (FDA) has approved a generic version of the anti-cholesterol drug Vytorin, which will be launched on the US market by Impax Laboratories Inc (Impax).

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 Vytorinand 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].

Related articles
Endo accused of Opana pay-for-delay

Endo launches generic version of Zetia

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Impax