Aurobindo Pharma arm receives FDA nod for Testosterone Cypionate injection

Drugmaker Aurobindo Pharma on Monday announced that its wholly-owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Testosterone Cypionate injection at concentrations of 100 mg/mL and 200 mg/mL in multi-dose vials and 200 mg/mL in single-dose vials. The product is set to be launched in November 2023.

According to research firm IQVIA, the approved product has an estimated market size of $226.8 million for the 12 months ending August 2023. This is the 169th abbreviated new drug application (ANDA) approval received from Eugia Pharma Speciality Group (EPSG) facilities.

Testosterone Cypionate Injection USP is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism.

In October, Aurobindo Pharma, along with Sun Pharmaceutical, recalled products from the US market owing to manufacturing issues, according to the US Food and Drug Administration. A US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market.

In September, Aurobindo Pharma stated that the US FDA had issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. At the end of the inspection, a Form 483 was issued with one observation, which is procedural in nature.

According to the FDA, a Form 483 is issued to a company’s management after an inspection when the investigator observes any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related acts.