Alembic JV gets USFDA nod for generic version of AndroGel

Indian Pharma major, Alembic Pharmaceuticals informed the bourses on Wednesday that its joint venture, Aleor Dermaceuticals Limited received tentative approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone gel, 1.62 per cent.

The above-mentioned drug is therapeutically equivalent to the reference listed drug product (RLD) - AndroGel 1.62 per cent of AbbVie Inc. The drug is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

According to data from IMS Health, Testosterone gel, 1.62 per cent (20.25 mg/1.25 gm actuation) has an estimated market size of US$ 107 million for twelve-month ending September 2020.

The company has a cumulative total of 136 ANDA approvals, including 117 final approvals and 19 tentative approvals from USFDA.

On Wednesday, the stock of Alembic Pharmaceuticals closed at Rs 978.60 per share, down by 1.78 per cent or Rs 17.70 per share on BSE, against a 1.56 per cent decline in the benchmark index. The 52-week high is recorded at Rs 1,128 and the 52-week low is Rs 436.10 on BSE.