The company has received final approval from the United States Food and Drug Administration (USFDA) to market Meclizine hydrochloride tablets in the strengths of 12.5 mg and 25 mg, the company said in a statement.
Drug firm Zydus Cadila on Wednesday said it has received nod from the US health regulator to market generic antihistamine Meclizine hydrochloride tablets.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Meclizine hydrochloride tablets in the strengths of 12.5 mg and 25 mg, the company said in a statement.
The drug will be manufactured at the group's manufacturing facility in Ahmedabad, it added. Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems, Zydus Cadila said.
The group now has 292 approvals and has so far filed over 390 abbreviated new drug applications (ANDA) since the commencement of its filing process, it added.
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