Amarin Corp Plc (AMRN)

[biowreck]

HD: Three-year New Use/New Clinical Studies Exclusivity. New indications or dosage forms of previously approved drugs can receive new use or new clinical study exclusivity. The application must contain reports of new clinical investigations conducted by the applicant. The exclusivity term runs for three years from NDA approval and it bars the FDA from approving any ANDA or 505(b)(2) application by another party that relies on the same clinical studies. This exclusivity can be coupled with a six-month pediatric exclusivity.