Aurobindo receives approval for Fenofibrate tablets

The Dollar Business Bureau

Aurobindo Pharma, a Hyderabad-based firm has announced that they have finally received the approval from US Food & Drug Administration (USFDA) for marketing and manufacturing of Fenofibrate Tablets.

The approved Abbreviated New Drug Application(ANDA) is a bio and therapeutic equivalent to the Reference Listed Drug(RLD) Tricor tablets manufactured by AbbVie Inc.

The launch of this product is expected in the first quarter of the current fiscal.

Aurobindo Pharma in a BSE filing said that the company has received final approval for the marketing and manufacturing of 48mg and 145 mg Fenofibrate tablets.

Fenofibrate tablet is used to treat high triglyceride and cholesterol level in the blood.

According to IMS health, the estimated market size of the approved drug is $412 million for a period of 12-month ending March 2016.

Aurobindo Pharma has 257 ANDA approvals from USFDA, of which 220 drugs have received final approval while 37 drugs have been tentatively approved.

The shares of the company are trading at a price of Rs. 801.75 on Bombay Stock Exchange.