PHARMACY

FDA warns of layoffs if Congress fails to renew PDUFA

BY Drew Buono

WASHINGTON Food and Drug Administration Commissioner Andrew von Eschenbach has told the agency’s employees that 2,000 of them could get layoff notices as early as next week if Congress fails to renew user fees for drugs and medical devices, according to the Associated Press.

The FDA and lawmakers are working to finalize the Prescription Drug User Fee Act, legislation that would renew user fees that would help the agency’s work.  In a letter to the employees, Eschenbach wrote, “All parties fully understand the importance of meeting the Sept. 21st deadline because no one underestimates or fails to appreciate the disruption and demoralizing impact that even the threat of a RIF is having on you and your families.”

The layoffs would take effect 60 days after issuance of a notice.  Both chambers of Congress are working on legislation that would renew the PDUFA program through 2012.

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Evista gets FDA approval for new use to reduce breast cancer risk

BY Drew Buono

INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.

The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.

The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.

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Cubist to ask for patent reissue for Cubicin

BY Drew Buono

LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.

Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016.  Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.

On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug.  Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.

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