Tuesday, July 1, 2008

Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA

The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing. The case concerns Mutual Pharmaceutical's generic version of GlaxoSmithKline's heart medication Coreg CR (carvedilol phosphate).
The details can be read here.

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