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FDA approves new packet option for AndroGel 1.62%

Issue: April 2013

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The FDA has approved a new packet option for testosterone gel 1.62%, according to manufacturer press release.

Testosterone gel (AndroGel, AbbVie) is considered a controlled substance and indicated for the treatment of hypogonadism.

According to the press release, the recommended starting dose is 40.5 mg applied once daily (or one-2.5 g gel packe, the equivalent of two pump presses with the metered-dose pump). Clinicians have the option to titrate up or down in 20.25 mg-dose increments (1.25 g gel packet). The new packet form allows patients the same option to titrate.

For more information, visit www.fda.gov.