NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky announces it has commenced an investigation of Antares Pharma, Inc. (“Antares” or the “Company”) (NASDAQ:ATRS) concerning possible violations of federal securities laws.
On October 11, 2017, the Company received a letter from the U.S. Food and Drug Administration stating that the agency had “identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments” for its product candidate Xyosted.
Then on October 20, 2017, Antares announced receipt of a Complete Response Letter from the FDA regarding the New Drug Application for Xyosted. The Company stated that the FDA could not approve the NDA in its present form due to concerns that Xyosted “could cause a clinically meaningful increase in blood pressure” and also noted the FDA’s concerns “regarding the occurrence of depression and suicidality.” To obtain additional information, go to:
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