Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing.

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing.

Testosterone Topical Solution actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Quoting IQVIA data, Alembic Pharma said Testosterone Topical Solution USP, 30 mg per pump actuation has an estimated market size of USD 21 million for twelve months ended March 2021.

Alembic Pharma has a cumulative total of 145 ANDA approvals (127 final approvals and 18 tentative approvals) from the USFDA.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular), focusing on commercialising dermatology products globally.