FDA panel votes in favor of Pfizer’s Fablyn
NEW YORK The benefits of Pfizer’s osteoporosis drug Fablyn outweigh its risks, a Food and Drug Administration panel said, recommending the drug for postmenopausal women in a 9-3 vote Monday.
The advisers on the panel said they could not determine whether deaths among patients using the drug were a statistically significant increase over deaths among those receiving a placebo.
But, they said, the decision was neither a clear rejection of the drug nor a clear endorsement.
Pfizer had maintained that numbers showing an increase in deaths among patients using the drug, known generically as lasofoxifene tartrate, were not statistically significant.
Judge orders Ely Lilly to unseal Zyprexa documents
NEW YORK A judge in the United States District Court for the Eastern District of New York said Friday he would unseal documents concerning Zyprexa, Eli Lilly’s schizophrenia drug.
Judge Jack Weinstein’s ruling was related to his granting of class-action status to a group of unions, pension funds and insurance companies alleging that the Indianapolis-based drug maker failed to disclose some of the drug’s side effects and marketed it for uses for which regulators had not approved it.
The documents date back to 2004, when several patients sued Lilly, alleging that Zyprexa (olanzapine) caused them to develop diabetes and gain excessive weight.
New York legislation: pharmacists can administer vaccinations
ALBANY, N.Y. Starting Dec. 4, pharmacists can apply to New York’s state government for certification to administer vaccinations, under legislation signed Friday by Gov. David Paterson.
The certifications will cost $100 every three years and require training. The shots will still require prescriptions.
The purpose of the bill, supporters said, was to increase the number of vaccinations in the state; in New York City, this could mean an additional 50,000 elderly.
“Allowing pharmacists to immunize would increase access to vaccinations, as pharmacies are open long hours, on weekends and most holidays,” said Sen. Charles Fuschillo Jr., a Long Island Republican who sponsored the bill.