Zydus Cadila gets USFDA nod to market anti-dementia drug
New Delhi: Zydus Cadila on Saturday said it has received final nod from the US health regulator to market Memantine Hydrochloride extended-release capsules used for the treatment of dementia of Alzheimer's type.
In a filing to the bourses, Cadila Healthcare, the listed entity of the Group said Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Memantine Hydrochloride extended-release capsules in the strengths of 7 mg, 14 mg, 21 mg and 28 mg.
The product will be manufactured at the group's manufacturing facility at Moraiya, Ahmedabad, it added.
The drug is used for treatment of moderate to severe dementia of Alzheimer's type, Cadila Healthcare said.
The group now has more than 130 approvals and has so far filed over 300 Abbreviated New Drug Applications (ANDAs), it added.
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