Zydus gets USFDA nod for Omega-3-Acid Ethyl Esters capsules
Omega-3-acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of certain blood fat (triglyceride), the company said in a statement.
New Delhi: Zydus Pharmaceuticals' US arm Nesher Pharmaceuticals Saturday said it has received final approval from the USFDA to market Omega-3-Acid Ethyl Esters Capsules USP (USRLD - Lovaza Capsules).
Omega-3-acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of certain blood fat (triglyceride), the company said in a statement.
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The group now has 267 approvals and has so far filed over 360 ANDAs (abbreviated new drug applications) since the commencement of the filing process in FY 2003-04.
ANDA is an application for a US generic drug approval for an existing licensed medication or approved drug.
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