Determination of non-prescription generic reference preparations: the case analysis
10.13220/j.cnki.jipr.2019.05.004
- Author:
Xiao-Xuan HONG
1
Author Information
1. Shihezi University
- Publication Type:Journal Article
- Keywords:
Caffeine tablets;
Generic drugs;
Over The Counter drugs
- From:
Journal of International Pharmaceutical Research
2019;46(5):347-354
- CountryChina
- Language:Chinese
-
Abstract:
There are two ways for marketing Over The Counter(OTC)drugs in the US: the OTC monographs and new drug application/simple application(NDA/ANDA) review procedures. New products that meet the final monograph can be marketed without FDA approval, but the reference preparations and standard preparations are not searchable in the FDA database, so the reference preparation cannot be determined for such products generally. For the convenience of finding out and confirming the US non-prescription generic reference preparation, this paper introduces the US OTC drug review procedure and inquiry method, taking the US OTC product caffeine tablet as an example to show how to determine the US OTC generic drug reference preparations, so as to provide a reference for the selection of reference preparations in the consistency evaluation of generic drugs in China.
