505(b)(2): Is it for you?




A 505(b)(2) is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method is a holistic approach for developing products that offer differentiated benefits and gains approval for new drugs in a fraction of the time and cost required by traditional paths.


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The 505(b)(2) process

Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act was established by the Hatch-Waxman Amendments of 1984 to allow sponsors to obtain approval of NDAs containing investigations of safety and effectiveness that were not conducted by or for the applicant, but for which the FDA has issued an approval. The section was added to avoid unnecessary duplication of studies already performed on the reference drug. However, sponsors must still provide any additional data necessary to ensure that the differences from the reference drug, or other existing information, do not compromise safety and effectiveness.


Because approval can rest in part on data already accepted by the FDA or otherwise available in the public domain, fewer and smaller studies may be required, thus mitigating costs and shortening development time. Today, 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from an existing or approved drug. Ideal candidates include:


   •   New indications

   •   Changes in dosage form, strength, formulation, dosing regimen or route of administration

   •   New combination products

   •   New active ingredients

   •   Prodrug of an existing drug


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505(b)(1) vs. 505(b)(2) – It’s a Different Animal

Discovering and developing safe and effective new medicines is a long, difficult and expensive process. Typically, a new drug application approved by the Food and Drug Administration (FDA) under the standard 505(b)(1) regulatory path has taken as much as 15 years and a nine-figure investment to work its way through the system. However, drugs approved under 505(b)(2), which can rely in part on data from existing reference drugs, can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at a much lower cost.




Additionally, unlike generic drugs approved under Section 505(j) where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five or even seven years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the NDA. It follows that the 505(b)(2) process may be more attractive to investors because, in addition to up to seven years of market exclusivity, the product differentiation can provide a significantly better market potential.


The 505(b)(2) pathway allows companies to get out of the competitive environment of generics

while still enjoying a development process that eliminates most preclinical studies as well as

extensive safety and efficacy tests, dramatically reducing costs and time to market.


Camargo can certainly assist with a complete 505(b)(1) or 505(j) application, but we are the industry leader in guiding sponsors through the 505(b)(2) process. Although there can be confusion on which process may be the best fit for a drug program, we will help you evaluate and discuss the ideal options for safety, speed and efficiency. The 505(b)(1) process is what the industry is familiar with; it is executed for new drugs like those discovered by big pharma. In contrast, the 505(b)(2) process takes an existing drug and makes small modifications, often significantly advancing the medication for the patients’ benefit.


According to 2012 data, the percentage of new, small-molecule drugs approved under the 505(b)(2) process has exceeded 80 percent or more. The rising tide of drugs approved under this strategy is a testament to its growing  importance in the drug development market.


Download our white paper: Why More Drugs Than Ever Are Approved Through 505(b)(2)>


Is 505(b)(2) for you?

Camargo’s expertise in drug approval and thorough understanding of the FDA and its evolving standards will put your product on the fast-track to market. Specializing in the 505(b)(2) pathway globally, our team executes a spectrum of small and large molecule development programs. We provide expert advice grounded in years of industry and regulatory experience to take you from discovery to post-approval marketing, with a full range of services for pharmaceutical and biotech development teams.


Camargo can help you reach cost-effective solutions, increase speed-to-market time and aid you in maintaining regulatory compliance. From concept to commercialization, Camargo is by your side every step of the way — you couldn’t ask for a better companion.


Download our white paper: Understanding the 505(b)(2) Approval Pathway >


Read more about Ready 4 Action, Camargo’s approach to evaluate the scientific, medical, regulatory and commercial viability of proposed drug products. >