RadioMedix wins FDA approval for generic Ga-68 PSMA-11 PET agent
RadioMedix has received FDA approval for its abbreviated new drug application (ANDA) for Gallium Ga-68 Gozetotide Injection — a generic formulation of the PSMA-targeted PET diagnostic widely known as Ga-68 PSMA-11. The approval, announced on 10 June 2026, covers PET imaging of PSMA-positive lesions in patients with prostate cancer and marks the Houston-based company's first approved commercial radiopharmaceutical product.
Alongside the approval, RadioMedix reported that the FDA completed an inspection of its SPICA Center manufacturing site — a 27,500 sq ft facility located north of Houston — with no Form 483 observations, indicating no inspectional observations of conditions that might constitute violations of current Good Manufacturing Practice regulations. The clean inspection outcome is a notable operational signal in a field where manufacturing quality and site readiness increasingly determine which developers can scale reliably.
The product and its manufacture
Ga-68 PSMA-11 targets prostate-specific membrane antigen, a protein overexpressed on prostate cancer cells, enabling high-sensitivity PET imaging to detect and localise disease. The ANDA pathway used by RadioMedix — typically reserved for generics that demonstrate bioequivalence to a reference listed drug — reflects the maturity of the PSMA-11 product class. The reference product, Illuccix (Telix Pharmaceuticals), received FDA approval in 2022, and Novartis's Pluvicto lutetium-PSMA therapy has further elevated the clinical profile of PSMA-targeted nuclear medicine as a diagnostic and therapeutic axis.
Ebrahim S. Delpassand, founder and chief executive of RadioMedix, framed the approval as a step toward improving cost-effective access. "FDA approval of our Ga-68 PSMA-11 ANDA represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost-effective and high-quality radiopharmaceuticals for patients," he said.
Market context and competitive landscape
The PSMA-PET imaging segment has expanded rapidly following the 2021 FDA approval of the originator Ga-68 PSMA-11 product from UCLA and UCSF, and subsequent approvals of F-18-based PSMA agents including piflufolastat (Pylarify, Lantheus) and flotufolastat (Posluma, Blue Earth Diagnostics). A generic entrant at competitive pricing could widen access in community and regional PET centres that have faced supply constraints or cost barriers with branded agents.
RadioMedix positions itself not only as a product developer but as a contract manufacturing partner through the SPICA Center, which holds 21 CFR Part 211-compliant clean rooms and quality control suites. This dual commercial model — proprietary pipeline alongside external manufacturing services — is increasingly common among specialist radiopharmaceutical developers seeking to offset the capital intensity of cyclotron and hot-cell infrastructure.
The company's broader pipeline centres on next-generation targeted alpha therapies, where the manufacturing knowhow demonstrated by the SPICA Center inspection result could prove a differentiating asset. Regulatory agencies have signalled heightened attention to radiopharmaceutical manufacturing standards as the sector attracts major capital from large pharmaceutical acquirers; a clean FDA inspection record strengthens RadioMedix's positioning ahead of potential partnerships or licensing discussions.
Near-term milestones for the company are likely to include commercial launch logistics for the approved Ga-68 PSMA-11 product and further regulatory filings supporting the therapeutic side of its pipeline.