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

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:

  • 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).

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

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