The FDA suspended plans to relaunch the cancer pain treatment drug Onsolis pending changes to manufacturing issues with the product, according to a Medcity New report.
The drug's pink coloring can fade over the course of its two-year shelf life, which can be confusing to patients. The FDA is requiring BioDelivery Sciences International to make formulation changes in Onsolis to prevent the color change over time. There are no safety issues noted with the drug.
Packages of Onsolis currently on shelves can still be used for pain treatment in cancer patients, but until the BDSI complies with the FDA's manufacturing requirement, no new product will be made or shipped.
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The drug's pink coloring can fade over the course of its two-year shelf life, which can be confusing to patients. The FDA is requiring BioDelivery Sciences International to make formulation changes in Onsolis to prevent the color change over time. There are no safety issues noted with the drug.
Packages of Onsolis currently on shelves can still be used for pain treatment in cancer patients, but until the BDSI complies with the FDA's manufacturing requirement, no new product will be made or shipped.
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