J&J restoring cancer drug supply to EU patients

Associated Press Modified: October 31, 2012 at 1:17 pm •  Published: October 31, 2012
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A week ago, Janssen ended its rationing of Doxil, known chemically as doxorubicin hydrochloride, for American patients. The company hopes to soon have approval from the Food and Drug Administration for a manufacturer to handle sterile vial filling in the U.S. for Doxil produced by Ben Venue, which makes sterile injectable drugs at its Bedford, Ohio, complex.

A subsidiary of German drugmaker Boehringer Ingelheim, Ben Venue said on Oct. 16 it had resume limiting manufacturing at the Ohio plant, where it's investing more than $300 million in upgrades. Still, most products it makes there won't be available for several more months.

The Ben Venue supply problem comes amid more than three dozen recalls by Johnson & Johnson since September 2009 for products it manufactures, from Tylenol and other nonprescription drugs to prescription medicines, contact lenses and defective hip implants.

Among the most recent recalls is one from August — just announced recently — involving three brands of staplers used in hemorrhoid and rectal surgery. According to the FDA, the devices can misfire, causing incomplete staple formation that can result in death, severe pain, bleeding, infection and damage to or blockage of the rectal canal.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma



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