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8 Jun 2011

Mylan Receives Approval for Generic Version of Aricept

Mylan subsidiary Matrix Laboratories Limited receives final approval from the FDA for its Abbreviated New Drug Application for Donepezil Hydrochloride (HCl) Tablets.

Mylan Inc. announced yesterday its subsidiary Matrix Laboratories Limited has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg.

 

The generic version of Eisai's Aricept? Tablets are used to treat dementia associated with Alzheimer's disease.

 

Donepezil HCl Tablets had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. Mylan Pharmaceuticals Inc. is launching this product immediately.

 

Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five

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