New Delhi: Drug firm Strides Shasun on Wednesday said it has received approval from the United States health regulator for generic Omega-3-acid ethyl esters soft gel capsules used for reducing lipid in the blood.
The company has received approval from the US Food and Drug Administration (USFDA) for its capsules which are the generic version of Lovaza capsules, Strides Shasun said in a filing to BSE. Strides Shasun has partnered with Par Pharmaceutical to market the product in the United States, it added.
Commenting on the development, Strides Shasun MD Shashank Sinha said: “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.”
The product to be manufactured in the company’s Bengaluru facility and will be launched immediately, Strides Shasun said.
As per IMS, the US market for the generic Lovaza is approximately USD 300 million per annum, it added. “The company’s Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia”.