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news.Actavis has secured final approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application for Buprenorphine 2mg and 8mg sublingual tablets, the generic version of Reckitt Benckiser's Subutex.
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Subutex is a medical treatment of opioid dependence.
The company plans to commence deliveries of the product shortly.
According to IMS Health data, Subutex had total sales of approximately $108m in the US for the 12 months ending 31 December 2014.
Ireland-based Actavis is a pharmaceutical company focused on developing, manufacturing and commercializing affordable generic and branded pharmaceutical products for patients through its more than 30 manufacturing and distribution facilities located around the world.
With commercial operations in more than 60 countries, the company develops medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.