Aurobindo Pharma receives FDA tentative approval for Duloxetine Hydrochloride Delayed Release Capsules

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Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the US FDA to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base).

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 product has a market size of approximately US$ 2.9 Billion for the twelve months ending June 2010 according to IMS.

The tentatively approved ANDA No. 090778 for Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) was filed with Paragraph IV certification with first to file status and is currently under litigation in the United States District Court for the Southern District of Indiana, Indianapolis Division [Eli Lilly and Company v. Aurobindo Pharma Limited and Aurobindo Pharma USA Inc, Civil Action No 08-CV-1595-RLY-JMS].

 

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