Zydus get USFDA nod to market Omega-3-Acid Ethyl Esters capsules

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.

The capsule may also raise good cholesterol (HDL) levels, it added. The drug will be manufactured at Nesher Pharmaceuticals' manufacturing facility located at St. Louis, Missouri, US. 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.