Lupin gets US FDA’s approval for Donepezil Hydrochloride Tablets

03 Nov 2015 Evaluate

Pharma Major Lupin has received final approval for its Donepezil Hydrochloride Tablets, 23 mg from the United States Food and Drug Administration (US FDA) to market a generic version of Eisai Inc.’s Aricept Tablets, 23mg. Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.

Lupin's Donepezil Hydrochloride Tablets, 23 mg are the AB rated generic equivalent of Eisai Inc.'s Aricept Tablets, 23mg and is indicated for the treatment of dementia of the Alzheimer's type. Aricept had US sales of $52.3 million (IMS MAT June 2015).

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.

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