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Home Industry News Janssen reaches agreement to continue Doxil production

Janssen reaches agreement to continue Doxil production

2nd January 2014

Janssen has reached an agreement to continue production of its Doxil ovarian cancer drug at the troubled Ben Venue Laboratories plant, owned by Boehringer Ingelheim.

The treatment has been solely produced at the Ohio factory for some time, but there has been a shortage ever since sterility issues forced Ben Venue to suspend operations and sign a consent decree with the US Food and Drug Administration (FDA) in November 2011.

However, the importance of the factory was underlined by the fact the agency allowed the plant to continue to manufacture several lines of essential drugs, including Doxil, until the contractor finally admitted defeat in October 2013.

Boehringer Ingelheim pulled out in late December, but Janssen spokeswoman Lisa Vaga said the company has "reached an initial agreement to lease some parts of the plant and steps are being taken to transition manufacturing". 

Despite this deal, the plans must receive the approval of the FDA and relevant health authorities before production of Doxil can be resumed.ADNFCR-8000103-ID-801677881-ADNFCR

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