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BRIEF-Antares Pharma ‍says received FDA letter regarding deficiencies of its drug Xyosted
October 12, 2017 / 9:10 PM / in 6 days

BRIEF-Antares Pharma ‍says received FDA letter regarding deficiencies of its drug Xyosted

Oct 12 (Reuters) - Antares Pharma Inc

* Antares Pharma provides Xyosted™ regulatory update

* Antares Pharma Inc - ‍anticipate receiving further clarification from FDA on or before prescription drug user fee act (PDUFA) date of October 20, 2017​

* Antares Pharma Inc - ‍intends to work with FDA to understand nature of deficiencies once identified

* Antares Pharma Inc - ‍received a letter from FDA regarding Xyosted

* Antares Pharma Inc - ‍ letter from U.S. FDA does not specify deficiencies identified with respect to review of Xyosted NDA​

* Antares Pharma Inc - got letter on Oct 11 stating FDA identified deficiencies precluding continuation of discussion of labeling, postmarketing needs at this time​ Source text for Eikon: Further company coverage:

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