Zydus Cadila has got final approval from the US Food and Drug Administration (USFDA) to market Lurasidone Hydrochloride Tablets USP in the strengths of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.
Ahmedabad: City-based Drugmaker, Zydus Cadila has received the final approval from the US health regulator to market Lurasidone Hydrochloride Tablets USP (US RLD – Latuda Tablets).
The company has got final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.
The product will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad.
The medication is used to treat certain mental/mood disorders such as schizophrenia, depression associated with bipolar disorder. It may also help to decrease hallucinations (hearing/seeing things that are not there).
The group now has 257 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is a global pharmaceutical firm which discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide.