Comparator Drugs for Selected Pharmaceutical Products Containing Biopharmaceutics Classification System (BCS) Class 4 Drug Molecules

For the effective implementation of FDA Circular No. 2013-014: List of Products Requiring Bioequivalence (BE) Studies as Part of the Application for Marketing Authorization in Addition to Rifampicin and the 11 Products Listed in Bureau Circular No. 2006-008, particularly on the provision requiring BE Studies for pharmaceutical products containing Biopharmaceutics Classification System (BCS) Class 4 drug molecules (i.e. low solubility, low permeability), the Center for Drug Regulation and Research (CDRR) hereby provides the following listing of comparator drugs for use in the BE Studies of pharmaceutical products containing BCS Class 4 drug molecules:

 

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