FDA approves new packet version of AbbVie testosterone gel

AndroGel in 1.25-g, 2.5-g packets approved

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

The recommended starting dose for AndroGel 1.62% is 40.5 mg of testosterone applied once daily as directed. Physicians also can titrate administration up or down in 20.25-mg increments of testosterone based on serum total testosterone levels.


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