Aurobindo Pharma subsidiary receives FDA nod for Hypogonadism treatment

Aurobindo Pharma announced on October 23 that its wholly owned subsidiary, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to produce and market a drug for the treatment of hypogonadism.

The approved drug is Testosterone Cypionate Injection USP, available in strengths of 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200 mg/mL) in Multi-Dose Vial, as well as 200 mg/mL in Single-Dose Vial. This formulation is deemed bioequivalent and therapeutically equivalent to Pfizer Inc.'s reference listed drug (RLD), Depo-Testosterone Injection, available in 100 mg/mL and 200 mg/mL.

Testosterone Cypionate Injection USP is prescribed for replacement therapy in males experiencing conditions linked to symptoms of deficient or absent endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The product is slated for launch in November 2023, and it holds an estimated market size of US$ 226.8 million for the twelve months leading up to August 2023, according to IQVIA.

Aurobindo Pharma notes that this approval marks the 169th ANDA approval (including 9 tentative approvals) from Eugia Pharma Speciality Group (EPSG) facilities, which manufacture both oral and sterile specialty products.