Zydus Receives Final Approval from USFDA for Two Products

Zydus Cadila has received the final approval from the USFDA to market Gemfibrozil Tablets USP 600 mg (US RLD – LOPID), and Aripiprazole Orally Disintegrating Tablets USP in strengths of 10 mg, 15 mg, 20 mg, and 30 mg (US RLD – ABILIFY DISCMELT Orally Disintegrating Tablets). Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. Gemfibrozil is also used to lower the risk of stroke, heart attack or other heart complications in certain people with high cholesterol and triglycerides who have not benefitted from other treatment methods. Aripiprazole is an atypical antipsychotic. The drug is used to treat certain mental/mood disorders, such as bipolar disorder, schizophrenia, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with other medication to treat depression. Both the drugs will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. In line with this, the group now has 215 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. – Medical Buyer Bureau