RadioMedix wins FDA ANDA approval for Ga-68 PSMA-11 PET imaging agent

RadioMedix has secured U.S. Food and Drug Administration (FDA) approval for its gallium-68 (Ga-68) gozetotide injection, known as Ga-68 PSMA-11, a prostate-specific membrane antigen (PSMA)-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer.

The FDA granted approval via an Abbreviated New Drug Application (ANDA), according to the company. In connection with the approval, RadioMedix completed an FDA inspection of its Spica Center manufacturing facility north of Houston, TX, with no Form 483 observations, the firm said.

The Spica Center is a 27,000-sq-ft radiopharmaceutical manufacturing facility designed for 21 CFR 211 compliance. It houses multiple clean rooms, quality control suites, and quality assurance systems, and supports the development and production of targeted diagnostic and therapeutic radiopharmaceuticals for internal programs and external partners, according to the company.