FDA approval of generic version of cancer drug doxorubicin hydrochloride liposome injection is expected to help resolve shortage of drug supply
FDA approved generic version of cancer drug doxorubicin hydrochloride liposome which is used to treat patients with ovarian cancer and currently faced with shortage supply.
- (1888PressRelease) March 19, 2013 - The U.S. Food and Drug Administration today approved the first generic version of the cancer drug DoxilŽ owned by Janssen Biotech, Inc. (doxorubicin hydrochloride liposome injection). Doxorubicin HCL liposome injection is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.
Doxorubicin hydrochloride liposome injection is currently on the FDA's drug shortage list of supply. 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 to address drug shortages so that patients can get the medicines they need when they need them," said Capt. Valerie Jensen, R.Ph., director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA. "For the past year, the FDA has been working to ensure that supplies of doxorubicin HCL liposome injection were not interrupted."
Generic drugs approved by the FDA to Indian manufacturers have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
The generic is made by Sun Pharma (Sun) and Taj Pharma Group (India). Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun's and Taj's generic version will be available in 20 milligram and 50 milligram vials for applicable markets.
In March 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced it would exercise enforcement discretion for temporary controlled importation of doxorubicin hydrochloride liposome injection generic, an alternative to DoxilŽ produced by Taj Phrama India under special authorised manufacturing to maximise the supply other than Janssen Biotech's DoxilŽ; enforcement discretion was also used to release one lot of Janssen's DoxilŽ made under an unapproved manufacturing process.
For the present time, FDA intends to continue exercising enforcement discretion for importation of generic doxorubicin hydrochloride liposome injection, as limited supplies of Doxil are available. Once supplies of Sun's and Taj's generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCL liposomal product.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
About Taj Pharmaceuticals Group (India):
Taj Pharmaceuticals Limited is a pharmaceutical company founded and based in India. The company manufactures pharmaceutical formulations and API for India and other countries, owning about 450 brands and 4000 generic licenses. The company was established in 1995 as an enterprise and in 2004 became a public limited company with about $1Bn in sales.
About Sun Pharma:
Established in 1983, listed since 1994 and headquartered in India, Sun Pharma is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and worldwide markets.
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