Alembic Pharmaceuticals JV receives USFDA final approval for Testosterone Gel

Alembic Pharmaceuticals 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 US$ 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.

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