Strides Shasun today announced that it has received approval from the United States Food & Drug Administration (US FDA) for Omega-3-Acid Ethyl Esters Softgel capsules, a generic version of Lovaza.

The US market for the generic Lovaza is approximately USD 300 million per annum, as per IMS, with five generic players including Par Pharmaceutical (Par), an Endo International Company.

The company has partnered with Par to market the product in the United States. The product to be manufactured in its flagship facility in Bangalore will be launched immediately.

Shashank Sinha, Managing Director stated, ''We are delighted with this important product approval, which came through after a long approval cycle of almost 60 months, due to significant regulatory changes.''

Shares of the company gained Rs 21.3, or 2.11%, to trade at Rs 1,029.45. The total volume of shares traded was 47,159 at the BSE (10.33 a.m., Wednesday).