Regulatory Focus™ > News Articles > New Bioequivalence Recommendations for Popular Drugs Released by FDA

New Bioequivalence Recommendations for Popular Drugs Released by FDA

Posted 25 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released updated draft guidances on bioequivalence (BE) recommendations for numerous popular products. The BE studies are used to support abbreviated new drug applications (ANDAs).

The draft guidances, released 25 January, use the processes described in Bioequivalence Recommendations for Specific Products (May, 2007) to formulate the BE recommendations. As a result of that guidance, FDA has released BE recommendations for several hundred active pharmaceutical ingredients, including acetaminophen, ibuprofen and warfarin sodium.

FDA is announcing the release of 62 new BE recommendations in the draft guidance, including progesterone, nitroglycerin, niacin, morphine, metformin HCl, levonorgestrel, fentanyl and atorvastatin.

Comments on the draft guidance for industry are due by 26 March 2012.


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