FDA Says No to Antares’ Testosterone Replacement Application

October 25, 2017

The FDA told Antares Pharma in a complete response letter that the agency could not approve the company’s application for its testosterone replacement therapy (testosterone enanthate).

The letter cited concerns the drug could increase blood pressure and cause depression and thoughts of suicide, the company said.

Antares said it will request a meeting with the FDA to discuss those issues and map out a path forward.

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