FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Jun 8 2011

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (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, which 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 of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.