The European Medicines Agency (EMA) has recalled a drug that is injected into the brain for brain cancer treatment, after inspectors found sterility issues at the Pacira plant in California where it is produced.
While the EMA says there have been no reports of infections, it is recalling DepoCyte from the 20 countries in the European Union where the prolonged release liposomal suspension is approved. The agency will let doctors continue to use it in patients where there is not a suitable alternative treatment and in countries where there are no approved alternatives, but warns they need to be watched closely for signs of infection.
No one from Pacira ($PCRX) could be reached for comment.
In Friday's warning, the EMA said a July inspection by regulators from France and the United Kingdom found a number of manufacturing deficiencies, suggesting a "lack of adequate sterility assurance" that pose a "theoretical risk of sterility failure."
Production was halted and finished batches are being held until the regulator is certain the problems have been fixed, confirmed by a re-inspection.
There is no indication that the FDA has ever had a problem with the plant. DepoCyte is one of three Pacira drugs that uses the firm's extended-release technology DepoFoam. DepoFoam encapsulates active drug ingredients in liposomes and can be tuned to release the drugs over a period of one to 30 days, the company explains on its website. The company licensed the technology to Novo Nordisk ($NVO) last year.
- EMA release
Related Articles:
Pacira's FDA nod marks win for extended-release tech
Pacira licenses DepoFoam to Novo Nordisk, plans IPO
Like what you're reading
Click here to get more news delivered to your inbox>>