US FDA approves generics for Actavis and Lupin

Switzerland-based generic drugmaker Actavis Group, now owned by US firm Watson Pharmaceuticals (NYSE: WPI) , says it has received tentative approval from the US Food and Drug Administration for guanfacine extended-release tablets 1mg, 2mg, 3mg and 4mg, a generic equivalent to UK drugmaker Shire's (LSE: SHPGY) Intuniv, used in the treatment of attention-deficit hyperactivity disorder (ADHD).

Based upon available information, Actavis believes that it is the first applicant to file an Abbreviated New Drug Application for Intuniv containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Intuniv generated US sales of around $342 million for the 12 months ending March 31, 2012, according to IMS Health quoted by Actavis.

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