A Brief Summary of Seven Different 505(b)(2) Approvals
According to the guidance, a 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval ‘were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted’ (21 U.S.C. 355(b)(2))’.
In other words, one of the primary advantages of submitting a 505(b)(2) is the potential of getting a drug approved based on studies already in the scientific literature, as opposed to repeating clinical trials.
PDG has compiled a brief summary of seven different 505(b)(2) approvals, including notable features and a tabular overview of each. Many generic companies are turning toward more complex dosage forms, 505(b)(2) development, and even biosimilars to hedge the increasingly overcrowded traditional markets.
The paper provides a variety of everyday issues to consider as you contemplate your next development project.
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