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Fewer generics approved in the US during 2012 Posted 15/03/2013

FDA approved fewer generics for the US market during 2012 than in 2011, according to a new report from Thomson Reuters.

A total of 506 generics were approved via abbreviated new drug applications (ANDAs) during 2012. The drugs approved were submitted by 92 sponsors from 16 different countries. This was a reduction from 2011, when 547 ANDAs were approved by FDA from 99 sponsors from 19 countries.

Indian companies gained the most FDA approvals for generics during 2012, with 205 Indian generics from 29 sponsors being approved. This compares to 171 generics being approved from 41 US-based sponsors during 2012.

2012 was also the year that US congress approved the Generic Drug User Fee Act (GDUFA). Legislation allowing FDA to collect several user fees under the GDUFA was approved by the US Congress on 21 September 2012 [1].

The fees are a supplement to funding FDA already receives from Congress. The US Generic Pharmaceutical Association (GPhA) praised Congress for its ‘swift action’ to pass this legislation. It is hoped that the collection of these fees will enable FDA’s Office of Generic Drugs to reduce its current backlog of pending applications, cut the average time required to review generic drug applications for safety and increase the number of plant inspections the agency carries out. Thus, leading to more generics approvals during 2013.

Some observers, however, have suggested that the fees could also have a negative impact if they turn out to be a significant barrier for smaller companies or limit the interest in products with small markets or slim margins.

Generic drugs now account for about 85% of the four billion prescriptions written in the US each year.


1.  GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 15]. Available from: www.gabionline.net/Policies-Legislation/FDA-gives-details-of-generic-drug-user-fees

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Source: Thomson Reuters

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