Polish regulators reject Polpharma application and withdraw Dutilox from market

Polish pharmaceutical regulators have taken significant actions regarding the availability and safety of specific medications. The Office for Registration of Medicinal Products (URPL) rejected an application from Polpharma regarding changes to the manufacturing and sterilization processes for Disulfiram WZF. This decision leaves the return of the drug, which is used to treat alcohol addiction, to pharmacies uncertain after a months-long shortage.

Separately, the Chief Pharmaceutical Inspectorate has withdrawn all batches of the drug Dutilox (duloxetine) from the market and issued a temporary ban on introducing new batches. This action follows a request from URPL due to high levels of nitrosamine, a potentially carcinogenic impurity. While the manufacturer, Farmak, disputes the regulatory assessment regarding acceptable impurity limits, the withdrawal aims to address risks associated with these contaminants.