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Antares Pharma says FDA found deficiencies in testosterone therapy application

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Antares Pharma says FDA found deficiencies in testosterone therapy application

The U.S. Food and Drug Administration found deficiencies in Antares Pharma Inc.'s new drug application for Xyosted, previously known as Quickshot Testosterone, which is for treating men with low testosterone associated with hypogonadism.

According to the company, the agency did not disclose the deficiencies, which were identified in the ongoing review of the application, but said that the findings prevent the continuation of discussions over labeling and post-marketing requirements or commitments at this time.

Antares expects to receive further clarification from the FDA on or before Oct. 20, the target date for completion of the review of the application.