Zydus receives USFDA final approval for Gemfibrozil Tablets USP and Aripiprazole Orally Disintegrating Tablets USP
Zydus Cadila has received the approval from the United States Food and Drug Administration (USFDA) to market the drug in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, the company said in a BSE filing.
Zydus Cadila said the drug will be produced at the group's formulations manufacturing facility at Moraiya, Ahmedabad.
Aripiprazole, an antipsychotic drug (atypical type), is used to treat mental/mood disorders such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder.
It is also used in combination with other medications to treat depression. It works by helping restore the balance of certain natural chemicals in the brain (neurotransmitters)
The group has more than 243 approvals, and so far filed over 330 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.
Shares of Cadila Healthcare, the listed entity of the group, were trading 0.08 per cent lower at Rs 347.90 apiece on BSE.
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