FDA Approves Sun's Generic Drug for Cancer
The first-ever generic version of cancer drug Doxil is now approved by The U.S. Food and Drug Administration, the agency announced Monday.
The drug approval is expected to alleviate the drug shortage in the country. Currently, Doxil or Doxorubicin hydrochloride liposome injection is on the FDA's drug shortage list.
Doxil is made by Johnson and Johnson and was approved in the U.S. in the year 1995 to treat ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma, reports Reuters Health.
FDA's announcement has increased the value of the company that has gained the approval - Sun Pharma Global FZE (Sun). The company's shares have increased by 4.5 percent, according to reports by Bloomberg Businessweek.
The agency also said that the generic forms of drugs have the same quality as that of the branded ones and that these generic drugs need to pass the quality tests as those passed by the standard brand-name drugs.
Last year, FDA had announced that it would be importing the cancer drug Doxil to offset the shortages in the country. The temporary arrangement was made between the agency and Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. to get the drug for cancer patients in the U.S.
"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," said Capt. Valerie Jensen, director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA.
For now, the generic drug will be available in 20 milligram and 50 milligram vials, the agency said. Also, FDA said that it will continue its enforcement discretion for importing Lipodox until the shortage is alleviated.