Natco Pharma Limited announced final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (FDA) for generic version of Armodafinil Tablets, 50 mg, 150 mg, and 250 mg. NATCO and its marketing partner Breckenridge Pharmaceutical, Inc, plan to launch this product in the US market immediately.
Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg tablets under Brand name Nuvigil in the US market. Nuvigil is a wakefulness promoting agent for oral administration.
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I have been using Nuvigil for over 5 years, and Mylan’s generic armodafinil for several months. Both were effective at helping me maintain wakefulness. Having been switched to Breckenridge armodafinil by pharmacy (they say the switch was simply because of what their supplier had), this new version has had absolutely no effect on improving wakefulness after 2 weeks of use. (I went without taking pill for 2 days to compare). Also concerned that irregular bowel movements that are 100% coincident with my use of Breckenridge generic are a (previously non-existent) side effect.
I have the same issue