Aleor Dermaceuticals gets FDA nod for Testosterone Gel
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.
Aleor Dermaceuticals gets FDA nod for Testosterone Gel
New Delhi: 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 per cent, 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 per cent, Alembic Pharmaceuticals said in a regulatory filing.
Testosterone Gel, 1.62 per cent is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
