Drugmaker Aurobindo Pharma subsidiary Eugia Pharma Specialities has acquired ultimate approval from the U.S. Food and Drug Administration (U.S. FDA) to fabricate and market Testosterone Cypionate Injection USP 1,000 mg/10 mL (100 mg/mL) and a pair of,000 mg/10 mL (200 mg/mL) in multi-dose vial and 200 mg/mL in single-dose vial.
Bioequivalent and therapeutically equal to reference listed drug Depo-Testosterone Injection, 100 mg/mL and 200 mg/mL of Pfizer, the authorized product’s estimated market measurement was $226.8 million for the twelve months ended August 2023, Aurobindo stated citing IQVIA numbers.
The product is anticipated to be launched in November, the corporate stated in a submitting.
Testosterone Cypionate Injection USP is indicated substitute remedy within the male in situations related to signs of deficiency or absence of endogenous testosterone, major hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
This is the 169th ANDA approval, together with 9 tentative approvals acquired, out of Eugia Pharma Speciality Group (EPSG) amenities, manufacturing each oral and sterile speciality merchandise, Aurobindo stated.
