Alembic Pharmaceuticals’ JV gets tentative approval for Testosterone Gel

25 Nov 2020 Evaluate

Alembic Pharmaceuticals’ joint venture (JV) -- Aleor Dermaceuticals (Aleor) 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 Inc. (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. The company has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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