Doxil is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma (a kind of skin cancer). Doxil has been in short supply since the production facility of Johnson & Johnson’s contract manufacturer Ben Venue Laboratories in Ohio was closed in November 2011 due to ‘significant manufacturing and quality concerns’ [1].

Both Johnson & Johnson and FDA have been doing all they can to alleviate shortages of the drug. Johnson & Johnson has been looking for an alternative supplier of the drug and also made an arrangement with Ben Venue Laboratories where the contract manufacturer carried out some steps of the production, but the drug was finished elsewhere. FDA on the other hand has sourced alternatives for the drug and has even released a lot of Johnson & Johnson’s Doxil made using an unapproved manufacturing process [2].  Despite their efforts, in a letter to physicians on 25 September 2013, Janssen said that based on current usage rates; they expect shortages of Doxil to hit in mid to late October 2013.

Janssen has admitted that they do not know how long the shortages will last and is therefore recommending that no new patients be started on Doxil. The company has also taken the unprecedented step of recommending that patients switch to generic doxorubicin.

FDA initially approved the temporary importation of Sun Pharmaceutical Industries (Sun Pharma’s) Lipodox (pegylated liposomal doxorubicin) from India as an alternative to Johnson & Johnson’s chemotherapy drug Doxil (doxorubicin) to alleviate shortages of Doxil. FDA then prioritized the company’s abbreviated new drug application for generic doxorubicin and finally approved the generic version of Doxil manufactured by Sun Pharma in February 2013 [2].

Related article

FDA says efforts to prevent drug shortages are working

References

1.  GaBI Online - Generics and Biosimilars Initiative. FDA approves new suppliers to alleviate cancer drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Generics/General/FDA-approves-new-suppliers-to-alleviate-cancer-drug-shortages

2.  GaBI Online - Generics and Biosimilars Initiative. Generic Doxil approval may help alleviate drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Pharma-News/Generic-Doxil-approval-may-help-alleviate-drug-shortages

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