Lupin receives USFDA approval for Testosterone Gel

The company has received approval from the United States Food and Drug Administration (USFDA) to market its generic testosterone gel, 1.62 per cent (20.25 mg/1.25 g pump actuation), Lupin said in a statement.

Mumbai: Drug firm Lupin recently said it has received approval from the US health regulator to market its testosterone gel used for treating low or no testosterone in men due to certain medical conditions.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its generic testosterone gel, 1.62 per cent (20.25 mg/1.25 g pump actuation), Lupin said in a statement.

The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Testosterone is the primary male sex hormone and an anabolic steroid. In male humans, testosterone plays a key role in the development of male reproductive tissues such as testes and prostate, as well as promoting secondary sexual characteristics such as increased muscle and bone mass, and the growth of body hair.

In addition, testosterone is involved in health and well-being and the prevention of osteoporosis. Insufficient levels of testosterone in men may lead to abnormalities including frailty and bone loss.

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The company's product is a generic version of AbbVie Inc's AndroGel 1.62 per cent, it added.