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# Novartis Radioligand Manufacturing Site Approved
- URL: https://www.fdaweb.com/novartis-radioligand-manufacturing-site-approved/
- Published: 2024-01-05T12:00:00.000Z
- Updated: 2026-09-14T14:19:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156087

FDA has approved Novartis’ Radioligand Therapy (RLT) manufacturing facility in Indianapolis, IN, for producing prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which has been on the agency’s [drug shortage list](https://www.accessdata.fda.gov/scripts/drugshortages/dsp%5FActiveIngredientDetails.cfm?AI=Lutetium%20Lu%20177%20Vipivotide%20Tetraxetan%20%28Pluvicto%29%20Injection&st=c&ref=fdaweb.com). The 70,000-square foot site is designed specifically for RLT manufacturing, and joins the company’s Millburn, NJ facility as the second RLT-dedicated facility in the U.S., according to a Novartis [release](https://www.novartis.com/news/media-releases/novartis-expands-production-pluvictotm-addition-its-largest-and-most-advanced-radioligand-therapy-manufacturing-facility-indianapolis?ref=fdaweb.com).

Pluvicto is approved for treating adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.