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PART 3: OTHER NOTEWORTHY DRUG AND BIOLOGIC APPROVALS AND REGULATORY ACTIONS

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In 2017 the U.S. Food and Drug Administration (FDA) approved 40 new small molecule drugs and granted 48 noteworthy biologic licenses. Among the 40 small molecules are two previously unapproved marketed drugs: calcium gluconate injection for symptomatic hypocalcemia (original approval 1941)1 and ascorbic acid injection (Ascor) for the short-term treatment of scurvy (initial approval 1947).2

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Part 1 looked back at first-in-class and “me-too” small molecule drug approvals, breakthrough therapies, new companion diagnostic tests for therapies targeting cancer, and a device approved to dampen opioid withdrawal symptoms. Part 2 reviewed novel and “me-too” biologics licensed in 2017. The remaining 2017 noteworthy FDA accomplishments are covered in this part of the series, including the drugs licensed for expanded indications, novel dosage forms, and new fixed-dose combination products, which are summarized in Table P3-1 and Table P3-2. A compilation of Other 2017 Noteworthy FDA Regulatory Activities is provided below. Throughout the series orphan (†), breakthrough ($), cancer therapy (#), and biologic (¶) designations are notated by the symbols †, $, #, and ¶, respectively.

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Table P3-1Established Drugs Approved for New (Non-Orphan) Purposes or as New Combinations or Novel Formulations in 2017 (see also Table 8. Marketed Drugs Licensed for Orphan Indications in 2017)

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