FDA gives Alembic tentative OK for generic AndroGel

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FDA gives Alembic tentative OK for generic AndroGel

By Sandra Levy - 11/25/2020

Adult males who have conditions associated with a deficiency or absence of endogenous testosterone will soon have a new generic treatment, pending the Food and Drug Administration’s final approval.

Alembic’s joint venture, Aleor Dermaceuticals has received the FDA’s tentative nod for testosterone gel.

The product is the generic of AbbVie’s AndroGel.

It is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Testosterone gel has a market size of roughly $107 million for the 12 months ended September 2020, according to IQVIA.

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