Alembic Pharma JV packs USFDA gesture on testosterone gel

Alembic Pharma JV packs USFDA gesture on testosterone gel


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  • Source: PTI

  • Date: 04 Mar,2021

Alembic Pharmaceuticals announced that its joint venture (JV), Aleor Dermaceuticals has obtained 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 men 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 received tentative approval for this ANDA.

According to 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 announcement was made during trading hours now, 4 March 2021.

Shares of Alembic Pharmaceuticals slipped 0.96percent 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 around the world.

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