The US Food and Drug Administration (USFDA) has granted final approval to Eugia Pharma Specialties Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, to manufacture and market leuprolide acetate injection.
The product is a bioequivalent and therapeutic equivalent of AbbVie Endocrinology Inc’s reference listed drug (RLD) Lupron injection (AbbVie).
Product will be released this month
This month, the product will be released. According to IQVIA, it has a market size of $83 million for the 12 months ending April 2022, said Hyderabad-based Aurobindo Pharma in a release.
The Eugia Pharma Specialty Group, which manufactures both oral and sterile speciality products, has received its 140th abbreviated new drug application, or ANDA (including eight tentative approvals).
The injection of leuprolide acetate is used to treat symptoms associated with advanced prostate cancer.
About EUGIA PHARMA
EUGIA PHARMA SPECIALITIES LIMITED is a Pharmaceutical and Medicine Manufacturing company based in Hyderabad, Telangana, India. EUGIA PHARMA SPECIALITIES LIMITED employs a total of 2,056 people across all of its locations. The EUGIA PHARMA SPECIALITIES LIMITED corporate family consists of 11 companies.
About Leuprolide injection
Leuprolide injection (Lupron Depot-PED, Fensolvi) is used to treat central precocious puberty (CPP; a condition in which girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] enter puberty too soon, resulting in faster than normal bone growth…) in children 2 years of age and older.
