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Actavis receives generic opioid approval and plans name change

Generics/News | Posted 27/02/2015 0 Post your comment

US generics maker Actavis announced on 20 February 2015 that it had received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Reckitt Benckiser’s Subutex (buprenorphine) sublingual tablets in dosages of 2 and 8 mg.

Buprenorphine is an opioid, a semi-synthetic derivative of thebaine. It is a mixed agonist–antagonist opioid receptor modulator that is used to treat opioid (usually heroin) addiction. The drug is used as an alternative to methadone and can prevent or reduce unpleasant withdrawal symptoms.

Subutex had total US sales of approximately US$108 million in 2014, according to IMS Health data.

In a separate announcement the company stated its intention to adopt ‘Allergan’ as its corporate name. This news follows the acquisition of Botox-maker Allergan by Actavis in November 2014 [1] and marks a move by the company to distinguish itself as a brand-name pharmaceutical provider. The company will, however, keep the Actavis name it says ‘for select geographic regions and product portfolios’.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Actavis buys Allergan and joins pharma top 10 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Pharma-News/Actavis-buys-Allergan-and-joins-pharma-top-10

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Source: Actavis