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.
Shares of Alembic Pharmaceuticals were trading 0.69 per cent lower at Rs 922.75 apiece on the BSE.