Published in Medical Letter on the CDC and FDA, December 26th, 2004
The two medicines (which are used in the treatment of AIDS) had been delisted by WHO in May this year due to noncompliance with international standards at the contract research organizations (CROs) hired by Cipla to conduct bioequivalence tests on the products.
As a consequence of WHO's delisting, the manufacturer carried out new bioequivalence studies to confirm that the two medicines are as effective as their respective brand-name counterparts. Further WHO scientific assessment and inspections have...
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