Data Sheet

505(b)(2): 10 Years and Running with 300+ Approvals

Format: PDF file | Document type: Data Sheet

505(b)(2): 10 Years and Running with 300+ Approvals

In 2003, the FDA unleashed the 505(b)(2) pathway. With a record 47 approvals in 2012, the pathway is helping product developers secure up to 7 years of market exclusivity.

Visit us at AAPS booth 4304 and read our white paper to learn more​.

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