Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market Gemfibrozil tablets and Aripiprazole orally disintegrating tablets in the US.
The company has received the US FDAs final clearance to market Gemfibrozil tablets in strengths of 600 mg and the other product in strengths of 10 mg, 15 mg, 20 mg, and 30 mg, Zydus Cadila said in a statement. Both the drugs will be manufactured at the groups formulations manufacturing facility at Moraiya, Ahmedabad, it added.
Gemfibrozil tablets are used together with the diet to treat high cholesterol and triglyceride levels in people with pancreatitis, Zydus Cadila said. The drug is also used to lower the risk of stroke, heart attack or other heart complications in people with high cholesterol and triglycerides, who have not benefited from other treatments, it added.
Aripiprazole is an atypical anti-psychotic. The drug is used to treat certain mental/ mood disorders, such as bipolar disorder, schizophrenia, Tourettes disorder, and irritability associated with autistic disorder, Zydus Cadila said.
It may also be used in combination with other medication to treat depression, it added. The group now has 215 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs), Zydus Cadila said.
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