FDA approves generic Ga-68 PSMA-11 radiodiagnostic for prostate cancer

The FDA has approved an abbreviated new drug application (ANDA) for gallium Ga 68 gozetotide injection (Ga-68 PSMA-11), a radioactive diagnostic agent for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with prostate cancer.

The FDA initially approved Ga-68 PSMA-11 in December 2020.² The agent is indicated for imaging of patients with suspected prostate cancer metastases who are candidates for definitive therapy and imaging of patients with suspected recurrent disease based on elevated serum prostate-specific antigen (PSA) levels.

The current approval adds another commercially available source of a PSMA-targeted radiotracer that has become increasingly integrated into prostate cancer care.

“FDA approval of our Ga-68 PSMA-11 Abbreviated New Drug Application represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost effective and high-quality radiopharmaceuticals for patients,” said Ebrahim S. Delpassand, MD, founder and CEO of RadioMedix, in a news release from the company.¹

In its announcement, RadioMedix stated that the approval was accompanied by a successful FDA inspection of the company's manufacturing facility, known as The SPICA Center, without issuance of Form 483 observations.

“We are also proud to have completed the FDA inspection with no Form 483 observations, which reflects the rigor of our quality systems, manufacturing capabilities, and teamwide commitment to regulatory excellence,” Delpassand added in the news release.¹ “As the radiopharmaceutical field continues to grow, quality, consistency, and regulatory readiness will be essential to ensuring these technologies can reliably reach patients.”

REFERENCES

1. RadioMedix announces receiving FDA approval of its generic Ga-68 PSMA-11 radiodiagnostic for prostate cancer. News release. RadioMedix, Inc. June 10, 2026. Accessed June 10, 2026. https://www.globenewswire.com/news-release/2026/06/10/3309646/0/en/radiomedix-announces-receiving-fda-approval-of-its-generic-ga-68-psma-11-radiodiagnostic-for-prostate-cancer.html
2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. US Food & Drug Administration. December 1, 2020. Accessed June 10, 2026. https://www.prnewswire.com/news-releases/fda-approves-first-psma-targeted-pet-imaging-drug-for-men-with-prostate-cancer-301182950.html