Aurobindo receives USFDA nod for anti-depressant drug

The capsules are the generic equivalent of Eli Lilly & Company's Cymbalta delayed-release capsules

 

Hyderabad-based drug maker Aurobindo Pharma Limited stated that it had received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Duloxetine Hydrochloride delayed-release capsules 20 mg (base), 30 mg (base) and 60 mg (base), which had been tentatively approved earlier.

The capsules are the generic equivalent of Eli Lilly & Company’s ‘Cymbalta’ delayed-release capsules. They are prescribed for the treatment of major depressive disorder and fall under the neurological therapeutic category.

According to IMS, the market size of the product is $5.4 billion for the twelve months ending September 2013.

Aurobindo said in a press release that it now had a total of 188 abbreviated new drug application approvals from USFDA.

The company's scrip was trading at Rs 300.20 on the BSE, up 0.76% over the previous day's close of Rs 297.95.