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News Details

Alembic Pharma's JV Aleor Dermaceuticals gets USFDA nod for Testosterone Gel

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04/03/2021 12:39
Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for Testosterone Gel, used for treating testosterone deficiency. The approved product is therapeutically equivalent to the reference listed drug product AndroGel 1.62%, of AbbVie Inc.

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62%, Alembic Pharmaceuticals said in a regulatory filing.

Testosterone Gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Quoting IQVIA data, Alembic Pharma said Testosterone Gel has an estimated market size of USD 86 million for 12 months ending December 2020.

Alembic Pharma has a cumulative total of 138 ANDA approvals (122 final approvals and 16 tentative approvals) from USFDA.