Current Advances in Drug Delivery Through Fast Dissolving/Disintegrating Dosage Forms

Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have been commercially available since the late 1990s. FDDFs were initially available as orodispersible tablets, and later, as orodipsersible films ...
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Approved and Marketed Fast Dissolving/ Disintegrating Drug Products

Pp. 378-430 (53)

Vikas A. Saharan, Anupama Singh and Vandana Kharb

Abstract

Websites of various drug regulatory agencies like US FDA, EMA, MHRA, PMDA and CDSCO were visited and information about approval and market authorisations of FDDF drug products’ was collected with an aim to provide updated lists. Additionally, information about marketed FDDF drug products was also retrieved from websites of pharmaceutical companies and other literature sources. This chapter comprehensively enlists various drug products approved and marketed in US, UK, Europe, Japan and India.

Keywords:

Bioequivalence, Brand, CDSCO, Controlled release, EMA, FDA, Film, Generic, MDT, MHRA, Mouth dissolving, ODT, Orally disintegrating, Orange book, Orodispersible, Patent, PMDA, Proprietary, Tablet.

Affiliation:

Department of Pharmaceutics, School of Pharmaceutical Sciences, Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences and Research, Balawala, Dehradun 248161, Uttarakhand, India.