Aurobindo Pharma’s arm gets FDA nod for hypogonadism drug

Testosterone Cypionate Injection USP is indicated replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

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Aurobindo Pharma on October 23 said its wholly owned subsidiary company, Eugia Pharma Specialities, received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market a drug that treats hypogonadism.

The company said it has received the approval to make Testosterone Cypionate Injection USP 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200 mg/mL) in Multi-Dose Vial and 200 mg/mL in Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Testosterone Injection, 100 mg/mL and 200 mg/mL of Pfizer Inc.

Testosterone Cypionate Injection USP is indicated replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

The product is expected to be launched in November 2023.

The approved product has an estimated market size of US$ 226.8 million for the twelve months ending August 2023, according to IQVIA.

Aurobindo Pharma said this is the 169th ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

At 1.12 pm, shares of Aurobindo Pharma traded flat at Rs 867 apiece on the BSE.