PHARMACY

FDARA attempt to limit citizens petitions not likely to have much effect, expert claims

BY Drew Buono

WASHINGTON According to Richard Silver, senior vice president of Equity Research for Lehman Brothers, the Food and Drug Administration’s Revitalization Act, which included language intended to limit the use of citizen petitions to block approvals of generic drugs, will not stop their use by brand companies, the FDA reported.

“Citizen’s petitions … we do not think they’re going to go away.  The backlog continues to grow,” Silver said last week during the Generic Pharmaceutical Association’s Annual Policy Conference in Washington, D.C. “We don’t think the citizen’s reforms will change the behavior of brand companies significantly.”

Two versions of the legislation are currently pending before a conference committee.

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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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