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FDA takes action on US cancer drug shortages

Sun Pharma and APP Pharmaceuticals approved to supply cancer drugs Doxil and methotrexate

The US Food and Drug Administration (FDA) has approved two new suppliers to cover shortages of the cancer drugs Doxil and methotrexate.

The US regulator cleared India-based Sun Pharma, and its distributor, Caraco Pharmaceutical Laboratories, to export Lipodox to make up for limited supplies of Doxil.

Both drugs are versions of doxorubicin hydrochloride liposome injection and used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma.

The FDA said the agreement was a “temporary, limited arrangement”, with short-term importation of unapproved foreign drugs sometimes allowed in rare cases where there is a shortage of an approved drug that is critical to patients.

The FDA also approved Illinois-based APP Pharmaceuticals to supply generic preservative-free methotrexate, which is used as chemotherapy in several cancers.

In addition to these new approvals, Hospira has accelerated the release of additional supplies of its methotrexate product, creating 31,000 vials to ship to US hospitals and health centres.

FDA Commissioner Margaret Hamburg said: “A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration.

“Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Doxil, which is manufactured by J&J's Janssen Products subsidiary, has been in short supply since June, 2011, due to manufacturing issues for its third-party contract manufacturer.

Meanwhile, supplies of methotrexate, versions of which are made by Mylan, Sandoz, Hospira and Bedford Laboratories, have suffered significantly due to suspension of manufacturing at the Ben Venue facility where Bedford's generic methotrexate is produced.

A significant increase in demand for the product has also had an effect on availability of the drug.

The news was welcomed by the US Generic Pharmaceutical Association (GPhA), which said patients and families waiting for these drugs would soon be able to get the medication they need.

The industry body also used the opportunity to highlight the need for adequate early warnings for any future shortages, alleviating the need for emergency measures.

This could include the development of the Accelerated Recovery Initiative (ARI), which would involve stakeholders across the supply chain working together improve communications and availability of information.

The comments echo statements made by president and CEO of the GPhA Ralph Neas in his first public presentation on October, 2011.

Speaking at an FDA workshop on the shortage problem he said that any solution required the combined efforts of brand manufacturers, active ingredient suppliers, component suppliers, wholesalers and distributors, group purchasing organisations, healthcare providers and the FDA.

Other therapy areas affected by the drug shortages include attention-deficit hyperactivity disorder (ADHD).

Supplies of several products, including Shire's Adderall XR and generic ADHD drugs from Teva, CorePharma and Sandoz, have been limited to difficulties in getting hold of the active ingredient, mixed amphetamine salts.

23rd February 2012

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