On January 13, we originally posted on this topic. An update was posted on February 5. This post provides the most recent update on this matter.
Yesterday, the Federal Circuit granted Teva’s petition for en banc rehearing....more
Statutory Basis For Label Carve-Outs -
Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more