Small BusinessWockhardt gets tentative nod from US FDA
Pharma major Wockhardt today said it has received tentative approval from the US drug regulator to market "Memantine HCl" tablets, used for the treatment of Alzheimer"s disease and dementia.
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The company has got "tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 5mg and 10mg tablets of Memantine HCl, the medicine can be used to treat moderate to severe stages of the diseases," Wockhardt said in a statement.
Memantine is the generic name of the brand Namenda, that is marketed by Forrest Laboratories in the US.
The patent covering this product is under litigation in the US courts.
Wockhardt and Forrest Lab have reached a settlement on their patent litigation, which allows the Mumbai-based firm to launch its generic version several months ahead of the patent expiration or as soon as any other generic version is launched.
According to the market analyst firm IMS, the total market for Memantine tablets in the US is about $1.1 billion and is the first in class of Alzheimer"s drugs.
"Wockhardt was amongst the first-to-file for an Abbreviated New Drug Application (ANDA) with paragraph IV certification on Memantine and is the first to get a tentative approval," Wockhardt Chairman Habil Khorakiwala said.
Memantine tablets will be manufactured at the US FDA certified formulation plant at Waluj in Aurangabad.The tablets were developed in-house, the company added.