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ARTICLE | Clinical News

FDA identifies deficiencies in Antares' Xyosted NDA

October 20, 2017 8:06 PM UTC

On Oct. 13, Antares Pharma Inc. (NASDAQ:ATRS) said FDA identified unspecified deficiencies in an NDA for Xyosted testosterone enanthate that preclude continuing discussions about labeling and postmarketing requirements at this time. The company had said it expects further clarification from the agency on or before the Oct. 20 PDUFA date, but did not provide an update in time for publication.

Antares said it received and responded to labeling comments from FDA for the NDA in September. The company submitted the NDA last December under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products...

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Antares Pharma Inc.