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PART 1: FIRST-IN-CLASS AGENTS, BREAKTHROUGH THERAPIES, ORPHAN INDICATIONS, COMPANION TESTS, AND NOVEL DEVICES

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In 2017 the U.S. Food and Drug Administration (FDA) approved 40 noteworthy new drug products and granted 48 noteworthy new biologic licenses. Among the 40 new drug products are:

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  • Seven pharmacological “firsts” (Table P1-1);

  • Twenty-eight new molecular entities that are pharmacologically similar to previously approved drugs (Table P1-2);

  • Three “follow-on” products (see Part 3); and

  • Two previously unapproved marketed drugs (see Part 3).

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Table Graphic Jump Location
Table P1-1.New Pharmacological Drug Classes Introduced in 2017
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Table Graphic Jump Location
Table P1-2.New Drugs Licensed in 2017 with Pharmacological Mechanisms Similar to Previously Marketed Entities

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