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FDA allows temporary import of Sun’s Doxil alt to ease shortage

By Nick Taylor , 22-Feb-2012

The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.

Since Ben Venue Laboratories stopped production last year Johnson & Johnson (J&J) has been unable to source Doxil (doxorubicin hydrochloride). The US Food and Drug Administration (FDA) is acting to restore supply by allowing the temporary import of a version of Doxil, Lipodox, sold by Sun Pharma.

Speaking at a press conference yesterday Margaret Hamburg, commissioner of the FDA, said Lipodox is now available and supplies will ramp up in the coming weeks. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said the move is a “major step forward” in ending the crisis.

Having approved the import the FDA expects to fully meet patient needs in the coming weeks. Sun Pharma sent a letter last month to notify healthcare professionals of the product’s availability.

Lipodox is manufactured at a Sun Pharma FDA-approved facility in Halol, India. The FDA said it only approves the temporary importation of drugs from overseas after it has evaluated the quality and safety of the product, which it has done eight times in the past 18 months.

Since President Obama passed an executive order in October the FDA has prevented 114 drug shortages, Hamburg said. Yesterday it published draft guidance to help companies understand its new powers and in-PharmaTechnologist will look into its implications in an article tomorrow.

Methotrexate supplies

The FDA has also taken steps to make methotrexate available. Expedited approval of preservative-free methotrexate manufactured by APP Pharmaceuticals will increase supply from March onwards.

Further supplies will come from Hospira which has expedited the release of 31,000 vials, more than one month’s of US demand, and has begun shipping to US hospitals. Until yesterday output was limited by a lack of API (active pharmaceutical ingredient) but Hospira has now found supplies.

Michael Ball, CEO of Hospira, said 100kg of API is being shipped to Hospira and it will increase production when it arrives. This will allow Hospira to ship a further 34,000 vials next week and release 55,000 vials in mid-March. Ball said this will cover current need and provide a safety stock.

Other manufacturers are also stepping up. The FDA is talking to Mylan and Sandoz Pharmaceuticals to make up for the loss of output from the suspension of work at the Ben Venue plant in Ohio, US.

Despite problems at its production plant Ben Venue has also contributed to methotrexate supplies. Having tested the safety of preservative-free methotrexate manufactured before the shutdown, Ben Venue has supplies for release in emergency situations as other producers ramp up their output.

We have a situation where methotrexate is no longer in shortage”, Hamburg said. The challenge now is to find solutions for the more than 200 other drugs the American Society of Health-System Pharmacists lists as being in short supply.

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