The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients.

The new draft bioequivalence guidance documents cover generics of HIV medicines Triumeq (abacavir/dolutegravir/lamivudine) and Tivicay (dolutegravir), pain killer aspirin, asthma treatment DuoResp Spiromax (budesonide/formoterol fumarate dihydrate) and acid relux treatment Nexium (omeprazole), among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of high cholesterol treatment Questran (cholestyramine), acne treatment Doryx (doxycycline), angina treatment Efient (prasugrel) and anti-convulsive medication Gabitril (tiagabine), see Table 2.

 Table 1: FDA new draft bioequivalence guidance documents

ER: extended release; FDA: US Food and Drug Administration.
 
Table 2: FDA revised draft bioequivalence guidance documents

DR: delayed release; FDA: US Food and Drug Administration.

The draft guidance documents recommend what in vivo and in vitro studies generics companies should carry out in order to demonstrate bioequivalence. The number of studies, the population to be studied, blood sampling time points and analytes to be measured in blood samples are also detailed in the draft guidance documents.

In total the FDA now has 1,321 product-specific guidelines with bioequivalence study recommendations. The agency also has an overarching guidance document on bioequivalence recommendations for specific products [1].

Comments on the draft guidance documents can be posted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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