REMODULIN® DRUG PRODUCTS

REMODULIN® DRUG PRODUCTS. As used herein, "Remodulin® Drug Products" means the treprostinil injection for subcutaneous or intravenous use products that are described in, and are the subject of, NDA No. 21-272, as supplemented or amended (except to the extent such supplement or amendment pertains solely to the Remodulin Implantable System or the DEKA pre-filled semi-disposable pump system). Remodulin® Drug Products expressly do not encompass treprostinil delivered through any other methods, including but not limited to... the Remodulin Implantable System or the DEKA pre-filled semi-disposable pump system and do not encompass any other UTC products such as Tyvaso and/or Orenitram. Remodulin® Drug Products also does not encompass any technology associated with any other UTC product(s) or any applications or uses of treprostinil other than the treprostinil injection for subcutaneous or intravenous use products that are described in, and are the subject of, NDA No. 21-272, as supplemented or amended (except to the extent such supplement or amendment pertains solely to the Remodulin Implantable System or the DEKA pre-filled semi-disposable pump system). View More