Palatin Technologies Inc has received full approval from the US FDA to market NeutroSpec, a novel-imaging agent, indicated for the diagnosis of appendicitis in patients with equivocal signs. NeutroSpec will be marketed and distributed by Palatin's strategic collaboration partner, Mallinckrodt Imaging, a business unit of Tyco Healthcare, according to a company release.
"I am delighted to have had the opportunity to work with Palatin and to see NeutroSpec progress to an approved product," said Sam Kipper, lead investigator for the NeutroSpec equivocal appendicitis clinical programme and director, Positron Emission Tomography & Nuclear Medicine for Pacific Coast Imaging, Irvine, California. He added, "NeutroSpec is a significant advancement in infection imaging and an important step forward for the nuclear medicine community. I look forward to incorporating it into my clinical practice."
Carl Spana, president and chief executive officer of Palatin, stated, "The approval of NeutroSpec represents a major milestone for Palatin. Mallinckrodt Imaging have significant marketing expertise in the medical imaging industry and I am confident that they will be highly effective in generating NeutroSpec awareness in the marketplace."
NeutroSpec, formerly known as LeuTechâ, is Palatin's proprietary radio-labelled monoclonal antibody product for imaging and diagnosing infections. NeutroSpec is marketed and distributed by Palatin's strategic collaboration partner, Mallinckrodt Imaging, a business unit of Tyco Healthcare.