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The FDA approved 40 new drugs and biologics of note in 2013. Eight are first-in-class agents indicated for the management of a variety of conditions (see part 1 of this series). Among the remainder are 22 newly approved drugs that are pharmacologically similar to others already marketed (see Table 69-3) and 10 new biologics. Although draft guidance on biosimilar product development was published by FDA in 2012, to date there have been no "follow-on biologics" approved in the U.S. under the new rules.1 On another note, the FDA Safety and Innovation Act of 2012 had a dramatic impact on pediatric drug approvals in 2013.2,3 The Act permanently reauthorized the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).4,5 Together, these two companion laws provide for an incentive (6 months of marketing exclusivity) and extend federal authority to enforce FDA requirements that drugs used in pediatric populations be reviewed for safety and efficacy. Supplemental pediatric indications were approved for at least 34 new and existing drugs and biologics in 2013.6,7,8,9,10,11 Other 2013 noteworthy FDA regulatory activities are summarized below. Table 69-4 lists established drugs that were "repurposed" for a new indication or significantly reformulated in 2013.

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Table 69-3.New Drugs Licensed in 2013 with Pharmacological Mechanisms Similar to Previously Approved Drugs

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