Abstract

ESSENTIALS OF REFERENCE LISTED DRUGS IN GENERIC PRODUCT DEVELOPMENT AS PER USA

Darshil Shah*, Prachi Gandhi* and Dr.Dilip.Maheshwari

ABSTRACT

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. A standard RLD may avoid possible significant variations among generic drug products and their brand name counterparts. Approved drug products list with therapeutic equivalence evaluation commonly known as “orange book”. It includes all products that have been approved by FDA for safety and effectiveness, alphabetically by ingredients in the products. Article included FDA’s enhanced refusal to receive standards for ANDAs. Special considerations of scoring, packaging and labeling.

Keywords: Generic, Medicine, RLD (reference listed dug), Orange book, Therapeutic Equivalence, ANDA.