Alembic Pharmaceuticals (Alembic), a vertically integrated research and development pharmaceutical company   on Thursday announced that its joint venture Aleor Dermaceuticals (Aleor) has received final 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 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).

Aleor had previously received tentative approval for this ANDA. Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of USD 86 million for twelve months ending December 2020 according to IQVIA.

Alembic has a cumulative total of 138 ANDA approvals (122 final approvals and 16 tentative approvals) from USFDA.

Shares of the company declined Rs 6.35, or 0.68%, to trade at  Rs 922.85.  The total volume of shares traded  was  5,553 at the BSE (11.32 a.m., Thursday).