Friday, November 10, 2006

Shire sues Andrx/Watson over generic Adderall

Shire Laboratories, Inc. has filed patent infringement suits in D NJ and SD Fla against Andrx Pharmaceuticals LLC and Andrx Corp. under the Hatch-Waxman Act in response to an Andrx new drug application [ANDA] for several generic versions of Adderall, a drug used to treat attention deficit hyper activity disorder (ADHD).

The complaints also name Watson Pharmaceuticals Inc., which has acquired Andrx.

Separately, on general background on ADHD and off-label uses, see the text:

In the context of continuing medical education (CME), lecturing doctors can answer questions about off-label uses, although they cannot initiate discussion of off-label uses. Thus, in the past, if someone asked about using modafinil for ADHD, the lecturing doctor could respond.


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