- CorMedix Inc (NASDAQ: CRMD) received a second Complete Response Letter (CRL) from the FDA for DefenCath, developed as a catheter lock solution to reduce catheter-related bloodstream infections in patients with renal failure receiving chronic hemodialysis via a central venous catheter.
- The letter states that DefenCath cannot be approved until deficiencies recently conveyed to the contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of the FDA.
- There were no other deficiencies related to DefenCath cited in the CRL, and the company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath.
- Related: CorMedix Refiles DefenCath US Application For Catheter-Related Bloodstream Infections.
- As part of the company's strategy to mitigate risks the compliance deficiencies, CorMedix has agreed with Alcami Corporation, a US-based contract manufacturer, to serve as an alternative manufacturing site for DefenCath.
- CorMedix expects to be able to submit a supplement to its NDA application around the end of Q1 of 2023.
- The company expects final marketing application approval after July 1, 2023.
- Price Action: CRMD shares are down 54.1% at $3.45 during the premarket session on the last check Tuesday.
Read at Benzinga