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FDA says approval of generic Doxil will ease cancer drug shortage

Allows Sun Pharma to manufacture its own version of the medicine

FDA headquarters

US regulators have taken the unusual step of fast-tracking approval of a generic version of Johnson & Johnson's cancer drug Doxil in order to try and alleviate nationwide shortages of the medicine that stem back to June 2011.

At the time, J&J's subsidiary Janssen placed the blame on delays at its third-party contract manufacturer Ben Venue Laboratories, but these problems were later compounded when Ben Venue issued a temporary suspension of manufacturing and distribution of drug products due to a series of violations in standards.

These issues have also affected other cancer drugs, including methotrexate, versions of which are made by Mylan, Sandoz, Hospira and Bedford Laboratories.

The FDA has now approved India-based Sun Pharma's generic version of Doxil (doxorubicin hydrochloride liposome injection), which is protected by orphan drug marketing exclusivity until May 2014, but only in a multiple myeloma indication. Generic patent protection for its other indications expired in 2009.

The regulator previously implemented measures to address the issue, including a “temporary, limited arrangement” in February 2012 for Sun Pharma to export its version of Doxil, which it markets as Lipodox, despite the fact it was yet to be approved by the agency.

However, Sun Pharma's copy has now been cleared for use in the treatment of ovarian cancer and multiple myeloma, meaning access for patients in the US with these conditions should be improved.

The FDA also said it expects to stop exercising “enforcement discretion” for any unapproved doxorubicin HCl liposomal product, including the exported Lipodox, once Sun Pharma's generic supplies are able to cope with the demand.

“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” said Captain Valerie Jensen, director of drug shortage staff, Center for Drug Evaluation and Research, FDA.

Janssen is also working to improve supplies of its own product, with its most recent statement on Doxil saying the company was “coordinating with the Food and Drug Administration (FDA) to release additional supply using an alternative manufacturing process”.

The statement, which was released on January 7, 2013, explained that although the process was not approved by the FDA, the product had undergone a full internal review by Janssen to ensure it met standards in both quality and safety.

Janssen said it was working with the FDA to gain approval for this new manufacturing process for Doxil, which involves collaboration between Ben Venue Laboratories (BVL) and another supplier.

5th February 2013

From: Sales, Regulatory

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