Andrx files ANDA for generic version of Shire's Adderall XR

UK drugmaker Shire has received a Paragraph IV notice letter from Andrx Pharmaceuticals, advising it that the US generics firm has filed an Abbreviated New Drug Application seeking approval for its copy-cat version of Shire's attention-deficit hyperactivity disorder drug, Adderall XR (mixed amphetamine salts). Shire noted that Andrx may not launch its generic drug before it receives final ANDA approval from the US Food and Drug Administration, adding that, if it decides to file a complaint on the Notice letter, the law suit triggers a stay of FDA approval of up to 30 months.