Alembic Pharma's JV Aleor Dermaceuticals gets tentative nod from USFDA for testosterone gel

New Delhi: Drug firm Alembic Pharmaceuticals on Wednesday said its joint venture Aleor Dermaceuticals has received tentative nod from the US health regulator for generic Testosterone Gel used for treating testosterone deficiency. Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62 per cent (20.25 mg/1.25 gm actuation), Alembic Pharmaceuticals said in a regulatory filing.

The product is a generic version of AbbVie Inc's AndroGel in the same strength, it added.

According to IQVIA data, Testosterone Gel, 1.62 per cent (20.25 mg/1.25 gm actuation) has an estimated market size of USD 107 million for twelve months ending September 2020, the filing said.

"The product is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and hypogonadotropic hypogonadism," it added.

The company has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from USFDA, Alembic Pharma said.