Bioequivalence testing data to be submitted in product license

Drug makers, who intend to apply for the product license for three medicines, will have to submit the bioequivalence data to the Korea Food and Drug Administration (KFDA). The KFDA said the notification is designed to prevent excessive number of me-too products.

The three medicines include amlodipine & its salts (including isomers), sibutramine its salts and clopidogrel & its salts.

The p...