Posted by ed_uk2010 on April 4, 2018, at 16:19:24
In reply to Re: Marplan shortage....., posted by PeterMartin on April 4, 2018, at 2:31:48
A generics manufacturer could decide to produce it. They would need to get their product approved, however, before they could sell it. A dossier would need to be submitted to the FDA with all the necessary data - showing things like bioequivalance studies versus the reference brand etc. The FDA would then decide whether data were satisfactory to support approval.
poster:ed_uk2010
thread:1097947
URL: http://www.dr-bob.org/babble/20180331/msgs/1097961.html