Two new suppliers of cancer treatments have been called upon by the US Food and Drug Administration to help the country cope with ongoing drug shortages.
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The agency has approved the temporary importation of Sun Pharma Global’s Lipodox from India to replace the acute shortage of Johnson and Johnson’s Doxil, used in treatment of ovarian, bone marrow and AIDS-related skin cancer.
It also approved APP Pharmaceuticals to make methotrexate, a drug used to treat children with leukemia.
FDA Commissioner Margaret Hamburg said in a statement, "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."
The shortage of both drugs followed the shutdown of Ben Venue Laboratories’ production facility in Ohio, which was closed to address manufacturing problems with some products.
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By GlobalDataThe facility produced the preservative-free methotrexate and makes Doxil for Johnson & Johnson.
The FDA has also issued a draft guidance today which details requirements for both mandatory and voluntary notifications to the agency regarding issues that could result in a drug shortage or supply disruption.
Caption: Methotrexate will be supplied by APP Pharmaceuticals to the US. Credit: Fdardel
