Lantheus Holdings, Inc. (LNTH) said its Abbreviated New Drug Application for Lutetium Lu 177 Dotatate or Lu-PNT2003, a generic version of LUTATHERA, has been accepted for filing by the FDA. Should the ANDA be approved by the FDA, the company believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.
LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lantheus licensed exclusive worldwide commercialization rights to 177Lu-PNT2003 from POINT Biopharma Global in December of 2022.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.