505 (b)(2) application

What is a 505 (b) (2) application?

An application submitted under section 505(b)(1) of the Federal Food, Drug and Cosmetics act for a drug for which one or more of the investigations relied on by the applicant for approval of the "application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted"

In simple words “505 (b)(2) application is a type of NDA for which one or more investigation relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference”

Section 505(b)(2) was added to the Food, Drug and Cosmetics act by the Drug Price Competition and Patent Term Restoration Act of 1984 (popularly known as Hatch-Waxman Amendments).

What type of information can an applicant rely on ?

• Published literature

• The agency's finding of safety and effectiveness of an approved drug.

What kind of application can be submitted as a 505(b)(2) application?

• New chemical entity (NCE)/new molecular entity (NME)

• Changes to previously approved drugs

Examples of changes to approved drug products for which 505(b)(2) application should be submitted

• Change in dosage form.

• Change in strength

• Change in route of administration

• Substitution of an active ingredient in a formulation product

• Change in formulation

• Change in dosing regimen

• Change in active ingredient

•  New combination Product

• New indication

• Change from prescription indication to OTC indication

• Naturally derived or recombinant active ingredient

• Bioinequivalence

What can't be submitted as 505(b)(2) applications?

• An application that is a duplicate of a listed drug and eligible for approval under section 505(j) (ANDA)

• An application in which the only difference from the reference listed drug is that the extent to which the active ingredient(s) is absorbed or otherwise made available to the site of action is less than the listed drug

• An application in which the only difference from the reference listed drug is that the rate at which its active ingredient(s) is absorbed or otherwise made available to the site of action is unintentionally less than that of the listed drug

Advantages of 505 (b)(2) application-

• A 505(b)(2) application may itself be granted 3 or 5 years of exclusivity

• Time-consuming , costly and duplication of clinical studies can be eliminated

• A 505(b)(2) application may be eligible to qualify for orphan and/or pediatric drug exclusivity

Challenge-

• 505(b)(2) application may be delayed due to patent or exclusivity protections covering an approved product

I found a useful link which is provided below, wherein you could get  useful information on differences between 2 types of NDA and ANDA, examples of medication approved under 505 (b)(2) application , Q & A related to 505 (b)(2) application, learning assessment etc

Understanding 505 (b)(2) by Lauren S. Schlesselman

Key Words- 505 (b)(2) application, Hatch-Waxman amendments.

Reference-

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf
http://www.cedrugstorenews.com/userapp/appdown.html?CFID=2677216&CFTOKEN=82970149

Other useful Links-

The 505(b)(2) Alternative— An NDA that Saves Time and Money

The 505(b)(2) New Drug Application – A Rapid Approval Route

The 505(b)(2): Drug Development Pathway