Alembic Pharma JV, Aleor Dermaceuticals gets tentative nod from USFDA for Testosterone Gel

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation). The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) AndroGel 1.62%, of AbbVie.

Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of $107 million for twelve months ending September 2020 according to IQVIA.

Alembic has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from USFDA.