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FDA Information

Doxepin was originally approved by the FDA in 1969. A topical formulation of doxepin (ZonalonŽ) was approved for pruritus associated with eczema in 1994.

On October 15, 2004 the FDA directed manufacturers of all antidepressants to include a Black Box warning, expanded warning statements, and clinical trial results detailing the increased risk of suicidality in children and adolescents.

 

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