Alembic Pharmaceuticals on Thursday announced that the company's joint venture Aleor Dermaceuticals Limited (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).
Aleor had previously received tentative approval for this ANDA.
Notably, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie Inc. (AbbVie).
Testosterone Gel 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).
According to IQVIA, Testosterone Gel has an estimated market size of US$86 million for twelve months ending December 2020.
So far, Alembic has a cumulative total of 138 ANDA approvals (122 final approvals and 16 tentative approvals) from USFDA.
At around 1.56 pm, Alembic was trading at Rs923.90 per piece down by 0.6% on Sensex.