Alembic Pharma JV Aleor Derma gets USFDA approval for Testosterone Gel
Vadodara: Pharma Major, Alembic Pharma, today announced that the company's joint venture Aleor Dermaceuticals Limited 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.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.