Best Evidence Analyses and Commentary


New topical strengths now available
Gabriella Lucarelli, PharmD Candidate, 2012

On April 29, 2011, Abbott received approval for Androgel (testosterone) 1.62%.  Androgel 1% has been available since February of 2000.  Both strengths are approved to restore testosterone in hypogonadal males.  The purpose of the Androgel 1.62% is to produce the same results with half the volume [1], [2].

Dosing 1%:        50-100 mg every morning

                         (available in gel packets and pump)[2]

 

Dosing 1.62%:  20.25-81 mg every morning

                        (available only in pump)[2]

 

  1. Abbott. Abbott Receives U.S. FDA Approval for AndroGel® 1.62% to Treat Men with Low Testosterone. Abbott.com. 29 Apr. 2011. Web. 27 July 2011.
  2. AndroGel® 1.62% [package insert]. North Chicago, IL: Abbott Laboratories. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf

 

On May 24, 2011 the FDA approved a new strength of Zyclara which offers clinicians greater flexibility when treating patients with imiquimod therapy.  Zyclara 2.5% has been approved for actinic keratoses(AK). The 3.75% cream was approved in March of this year and has an additional indication for both genital and perianal warts.  The main advantage of the 2.5% concentration is efficacy of the product with better tolerability to the most common side effect of imiquimod agents, local skin reactions [1],[2]

 

  1. "FDA Approves Zyclara® (imiquimod) Cream, 2.5%." Graceway Pharmaceuticals, LLC. 19 July 2011. Web. 26 July 2011.
  2. Zyclara[package insert]. Graceway Pharmaceuticals, LLC., Bristol, TN;  March 2011. http://www.gracewaypharma.com/sites/default/files/products/Zyclara%20Full%20PI.pdf. Accessed July 27, 2011.

 


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