Aurobindo Pharma Receives US FDA Approval for Testosterone Cypionate Injection

23 Oct 2023 , 01:54 PM

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 manufacture and market a drug for treating hypogonadism.

The approved drug is Testosterone Cypionate Injection USP, available in 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. It is bioequivalent and therapeutically equivalent to Pfizer Inc.’s reference listed drug (RLD), Depo-Testosterone Injection, in both 100 mg/mL and 200 mg/mL strengths. Testosterone Cypionate Injection USP is indicated for replacement therapy in males with conditions associated with testosterone deficiency, including primary hypogonadism and hypogonadotropic hypogonadism.

The product is expected to be launched in November 2023 and is estimated to have a market size of approximately US$ 226.8 million for the twelve months ending August 2023, according to IQVIA.

This approval marks the 169th ANDA (Abbreviated New Drug Application) approval, including 9 tentative approvals, from the facilities of Eugia Pharma Speciality Group (EPSG), which manufactures both oral and sterile specialty products.

As of 1.51 pm, shares of Aurobindo Pharma were trading flat at Rs 867.45 apiece on the NSE.