US regulatory nod for Zydus drug to treat dementia

We have received final approval from USFDA to market Memantine Hydrochloride tablets: Zydus

The US Food and Drug Administration has approved a drug by Zydus Cadila used to treat dementia of the Alzheimer's type, the Indian pharmaceutical company said on Wednesday.

"We have received the final approval from the USFDA to market Memantine Hydrochloride tablets USP, 5 mg and 10 mg, used for the treatment of moderate to severe dementia of the Alzheimer's type," said the city-based drug major in a regulatory filing on the BSE.

The drug will be produced at the company's formulations manufacturing facility at Moraiya in the city.

"We have 120 regulatory approvals and filed for 300 ANDAs (Abbreviated New Drug Application) for licensed medication since the filing process began in 2003-04," added the filing.