Alembic Pharmaceuticals announced that its joint venture (JV), Aleor Dermaceuticals has received the final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for testosterone gel, 1.62%.
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 Dermaceuticals (Aleor) had previously received tentative approval for this ANDA.
As per IQVIA, testosterone gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of $86 million for twelve months ending December 2020. The drug maker has a cumulative total of 138 ANDA approvals (122 final approvals and 16 tentative approvals) from USFDA. The announcement was made during trading hours today, 4 March 2021.
The drug maker reported 25% jump in consolidated net profit to Rs 293 crore on a 9% rise in net sales to Rs 1,314 crore in Q3 FY21 over Q3 FY20.
Shares of Alembic Pharmaceuticals slipped 0.96% to Rs 920.25 on BSE. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
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