FDA approves first generic version of Genentech chemotherapy pill
SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.
The FDA announced the approval of Teva Pharmaceutical Industries’ capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they’ve spread to other parts of the body.
The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.
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FDA bars drugs from third Ranbaxy plant
SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs’ plants in India, the agency said Monday.
The FDA said it had issued an import alert concerning drugs from the plant, in the Indian city of Mohali. An import alert means that customs officials can seize drugs from the plant when they reach the U.S. border, and the agency said the alert would remain in place until the company complies with U.S. drug-manufacturing requirements, known as current good manufacturing practices, or CGMP. Ranbaxy could not be reached for comment.
Mohali is 1-in-3 Ranbaxy manufacturing plants in India under an import alert, the other two being plants in Paonta Sahib and Dewas. The latter two have been under import alerts since 2008. The FDA found "significant CGMP violations" at the Mohali plant during inspections in September and December 2012, including failure to adequately investigate problems or establish procedures to ensure manufacturing quality. The company will be prohibited from selling drugs from the plant in the United States until it has fully addressed the issues to the FDA’s satisfaction, the agency said.
"The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.s. market meet federally mandated quality standards," FDA Center for Drug Evaluation and Research compliance office director Howard Sklamberg said. "We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country."
Ranbaxy has been plagued by poor quality control of drugs made in India for years. Why do we permit ANY Ranbaxy products to be sold in the US at all?
Sears plans to get $1 billion loan
HOFFMAN ESTATES, Ill. — Sears Holdings is hoping to obtain a new loan in order to reduce borrowings from an older loan agreement, the company said Monday.
Sears Holdings, the parent company of mass merchandiser Kmart, said it had issued a notice that it intended to obtain an incremental term loan of up to $1 billion.
The company said that if it went through, the loan would be issued under an existing $3.3 billion revolving facility credit line and would be used to reduce borrowings under it. The company said it hoped to secure the incremental term loan on the same collateral as the revolving facility, and that it would mature in June 2018.
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