SCYNEXIS, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From The FDA For Antifungal Agent SCY-078 For Oral Use
2/21/2014 9:05:24 AM
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Drug discovery and development company SCYNEXIS, Inc., today announced that the Food and Drug Administration (FDA) designated SCY-078 as a Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis. The QIDP designation, provided under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act, allows SCYNEXIS to have priority review, eligibility for fast-track status, and an additional five years of market exclusivity in the U.S. for SCY-078.
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