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Eugia Pharma Specialties Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market leuprolide acetate injection.
The product is a bioequivalent and therapeutical equivalent of the reference listed drug (RLD) Lupron injection of AbbVie Endocrinology Inc (AbbVie).
The product will be launched this month. It has an estimated market size of $83 million for the 12 months ending April 2022, according to IQVIA, Hyderabad-based Aurobindo Pharma said in a release.
This is the 140th abbreviated new drug application, or ANDA (including eight tentative approvals received), from the Eugia Pharma Specialty Group, which manufactures both oral and sterile speciality products.
Leuprolide acetate injection is used to treat symptoms associated with advanced prostate cancer .
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