Camargo Launches New Brand at GPhA as 505(b)(2)

From РFebruary 4, 2015

Camargo Pharmaceutical Services, will reveal its new brand at the Generic Pharmaceutical Association (GPhA) Annual Meeting.

The FDA 505)b)(2) application

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 the Investigational New Drug (IND) applications are filed today, 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.