FDA GENERIC RULING
January 1st, 2003
BY PHILIP FINE
A US federal judge has ruled that an approval letter with a delayed effective
date given by the Food and Drug Administration (FDA) should be considered merely a tentative approval and does not give a manufacturer the legal right to begin
marketing a medicine. The judge was ruling against Barr Laboratories' bid to market a generic version of tamoxifen tablets, which the company had expected to release last August. He quashed a bid by the generic manufacturer to overturn FDA restrictions on selling a product ahead of its release. The FDA had ...
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.