Antares Pharma (ATRS) : FDA found deficiencies in the drug Xyosted

Antares Pharma (ATRS) announced Thursday that the U.S. Food and Drug Administration had found deficiencies in the drug Xyosted (testosterone enanthate) during its review process, the company said in a statement. Antares submitted the Xyosted application in December 2016. Antares stock was up 60% this year,

 

Antares Pharma received FDA letter - identified deficiencies as part of their ongoing review of the New Drug Application for XYOSTED

• Co announced that, on October 11, 2017, the Company received a letter from the FDA stating that, as part of their ongoing review of the New Drug Application (NDA) for XYOSTED (testosterone enanthate) injection, they have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time. The letter does not specify the deficiencies identified by the FDA and there has been no further clarification of the deficiencies by the FDA at this time.
• Anticipates receiving further clarification from the FDA on or before the Prescription Drug User Fee Act (PDUFA) date of October 20, 2017.