Association of Pharmacy Professionals

Mini Review 2018

 JAN-JUN/JUL-DEC 2018 ISSUE 
APP Scientific Updates 2018;6(1-2)

THE 505 (B) (2) PATHWAY: OLD DRUG IN NEW PACKET

Dahiya S*
Department of Pharmaceutical Sciences
Pharmaceutical Research, Development and Processing Laboratory
School of Pharmacy, University of Puerto Rico-Medical Sciences Campus, San Juan, PR, USA
sunita.dahiya@upr.edu

Drug development process is expensive, time-consuming and risky affair. To comply with FDA approval criteria, companies need to invest enormously; even though the process does not guarantee the success. There are two main FDA approval processes for the products to reach the market, which are known as New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). This mini review concisely addresses the rationale of 505 (b) (2) pathway that is hybrid between these two FDA approval approaches. The 505 (b) (2) approach has become prominent over the time for the pharmaceutical drug development companies that wish to ease the product approval with much less efforts, resources and revenue as compared to full NDA, yet meeting the unmet therapeutic needs by launching superior quality products in less time and efforts, consequently earning good business and surviving in this competition-based industry.

 Keywords: Drug development, FDA, NDA, ANDA, 505 (b) (2)

APP Sci. Updates
2018; Vol. 6, No. 1-2, A1-A4.
(Received: Oct 11, 2018 / Accepted: Oct 31, 2018)

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