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Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration to manufacture and market Duloxetine Hydrochloride delayed-release capsules.
The capsules are the generic equivalent of Eli Lilly & Company’s Cymbalta delayed-release capsules and are indicated for the treatment of major depressive disorder under the neurological (CNS) therapeutic category.
The market size of the product is estimated to be $5.4 billion for the 12 months ended September 30, 2013 according to IMS.
The Hyderabad-based company has 188 ANDA approvals from USFDA, according to a release issued on Friday.
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