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Strides Shasun has received approval from the United States health regulator for generic Omega-3-acid ethyl esters softgel capsules used for reducing lipid in the blood.
The company’s has received approval from the US Food and Drug Administration (USFDA) for its capsules which are generic version of Lovaza capsules, Strides Shasun said in a filing to BSE today.
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 at the company’s Bengaluru facility will be launched immediately, Strides Shasun said.
As per IMS, the US market for the generic Lovaza is approximately $300 million per annum, it added.
“The company’s Omega-3-acid ethyl easters capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.''
Shares of Strides Shasun were trading up by 0.64 per cent at Rs 1,014.65 on the BSE.
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