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Regulatory Focus™ > News Articles > Draft Guidance for Nitroglycerin, Rifaximin Products Released by FDA

Draft Guidance for Nitroglycerin, Rifaximin Products Released by FDA

Posted 13 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new draft guidance documents on 13 February covering rifaximin tablets, nitroglycerin metered spray/sublingual products and nitroglycerin metered aerosol/sublingual products.

The draft guidances cover bioequivalence (BE) recommendations for both nitroglycerin and rifaximin products, particularly BE testing used to support Abbreviated New Drug Applications (ANDAs).

The draft guidances for nitroglycerin products are "revised versions of previously published draft guidances on the subject," while the rifaximin guidance is brand new.

Comments on the draftguidances are due before 13 April, 2012.



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