Generic cancer drug approved by US FDA
The first generic version of the cancer drug Doxil has been approved for use in the US by regulatory body the FDA. The generic Doxil (doxorubicin hydrochloride liposome injection) is made by Sun Pharma and can be used to treat treat ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
The original Doxil is made by Johnson &, Johnson and is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages.
“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. For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”
Capt. Valerie Jensen, R.Ph., director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA.
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