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A 505(b)(2) is a new drug application which 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 gains approval for new drugs in a fraction of the time and cost required by traditional paths.

In the fiscal year 2006, approximately 20% of new small molecule drugs were approved through the 505(b)(2) process; two years later, more than half of the new small molecule drugs approved in the United States were based on this strategy. Judging from the rate at which we are filing Investigational New Drug (IND) applications today, we expect that the percentage of 505(b)(2) approvals will be greater than 80% within the next few years.

The reasons behind the remarkable success of 505(b)(2) are twofold. 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. 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 type of clinical data included in the NDA.

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.

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 a previously 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
• Pro-drug of an existing drug

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