This is an action related to submitting to the FDA ANDA No. 204920 (“Defendants’ANDA”) and by submitting Drug Master Files (DMF), including DMF #23120. Defendants’ANDA seeks the FDA’s approval to manufacture, use, or sell commercially their proposed naproxen/esomeprazole magnesium delayed release tablets, 375 mg/20 mg and 500 mg/20 mg(hereinafter referred to as the “ANDA Products”), containing the active ingredients naproxen and esomeprazole magnesium, prior to the expiration of the patents-in-suit, as a generic version of the VIMOVO ® product.
Author : Ch.SureshArchives
July 2014
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