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Generic Doxil approval may help alleviate drug shortages Posted 08/02/2013

FDA announced on 4 February 2013 that the agency had approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).

Liposomal doxorubicin is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma (a kind of skin cancer).

The drug is currently on the FDA’s drug shortage list. FDA has been prioritizing review of drugs on the shortage list, as well as allowing the temporary import of generics from India without prior FDA approval [1] in order to try and alleviate the shortages in many essential medicines.

Doxil has been in short supply since Ben Venue Laboratories’ production facility in Ohio, USA, was closed in November 2011 due to ‘significant manufacturing and quality concerns’. The company made Doxil for Johnson & Johnson [2].

Captain Valerie Jensen, Director of Drug Shortage Staff at the Center for Drug Evaluation and Research at FDA said that ‘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’. She added that during 2012 ‘FDA has been working to ensure that supplies of doxorubicin hydrochloride liposome injection were not interrupted’.

As part of this effort to prevent interruption of the supply, FDA has also used its discretion to release one lot of Johnson & Johnson’s Doxil made under an unapproved manufacturing process.

The generic liposomal doxorubicin approved by FDA is manufactured by Sun Pharmaceutical Industries (Sun Pharma) and will be available in 20 mg and 50 mg vials. Sun Pharma also supplied generic liposomal doxorubicin, via its authorized distributor, Caraco Pharmaceutical Laboratories, without prior FDA approval, as part of FDA’s drug shortage measures.

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1.  GaBI Online - Generics and Biosimilars Initiative. FDA says efforts to prevent drug shortages are working [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 8]. Available from: www.gabionline.net/Pharma-News/FDA-says-efforts-to-prevent-drug-shortages-are-working

2.  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 Feb 8]. Available from: www.gabionline.net/Generics/General/FDA-approves-new-suppliers-to-alleviate-cancer-drug-shortages

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Source: FDA, Sun Pharma

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