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Why More Drugs Than Ever Are Approved Through 505(b)(2)

Bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.

Discovering and developing safe and effective new medicines is a long, difficult, and expensive process. Typically, a new drug application (NDA) 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.

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