Last Updated on November 26, 2020 by The Health Master
Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (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 US$ 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 US FDA.