Aurobindo Pharma receives USFDA approval for Duloxetine Hydrochloride Delayed Release Capsules

Aurobindo Pharma Limited has received the final approval from the US Food & Drug Administration to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) [ANDA No.090778], which was earlier tentatively approved.

Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) are the generic equivalent of Eli Lilly & Company's Cymbalta® Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base). Duloxetine Hydrochloride Delayed-Release Capsules are indicated for the treatment of for the treatment of major depressive disorder (MDD) and falls under the Neurological (CNS) therapeutic category. The market size of the product is estimated to be US$5.4 Billion for the twelve months ending September 2013 according to IMS.

Aurobindo now has a total of 188 ANDA approvals (163 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Shares of Aurobindo Pharma Ltd was last trading BSE at Rs.309.85, up by Rs.11.90 or 3.99%. The stock hit an intraday high of Rs.311.35 and intraday low of Rs.295.50.

The total traded quantity was 3.74 lakh shares as compared to 2 week average of 2.19 lakh shares.

Source : Equity Bulls

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