FDA addresses Tamiflu shortages
ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.
"The FDA is working hard to make sure that medicine to treat the flu and its symptoms are available for all who need it," FDA commissioner Margaret Hamburg told journalists during a conference call Friday. "Some locations may experience intermittent, temporary shortages of the oral suspension form of the antiviral, Tamiflu, which is the liquid version often prescribed for children for the remainder of the flu season. But the FDA has been working with the manufacturer, Genentech, to increase supply and is reminding healthcare professionals that FDA-approved instructions on the label provide directions for pharmacists on how to make a liquid form of Tamiflu from the Tamiflu capsules if the oral suspension product is not available."
Hamburg noted that Tamiflu 30-mg and 40-mg capsules remain available, and pediatric patients 1 year of age and older can be dosed correctly using the 30-mg and 40-mg capsules. "However, pediatric patients less than 1 year of age should be given Tamiflu oral suspension, preferably the commercial oral suspension product or if that isn’t available, then the suspension prepared by the pharmacist according to the current label instructions," she said.
While Tamiflu 75-mg capsules currently are available, supplies may run low if many pharmacies have to use the capsules to prepare an oral suspension for pediatric patients or to fill large numbers of prescriptions for adult patients, Hamburg acknowledged. "So to help avoid a shortage, the FDA is now allowing Genentech to distribute 2 million units of Tamiflu at the 75-mg capsule level that have an older version of the package insert," she said. "This additional supply is the same medicine as the product currently in distribution, but does contain an older version of the package insert — it’s important to note that this medicine is fully approved. It is not outdated."
The older labeling doesn’t have the new version of the instructions on making an oral suspension from the 75-mg capsules and new dosing information for treatment of pediatric patients two weeks to less than 1 year of age, Hamburg advised.
Hamburg also updated reporters on developments in vaccine production. "In the last year time frame, FDA has approved four new vaccines," she said. "We have approved a new cell-based vaccine at the end of November, which is an important advance in terms of not depending on [eggs] and being able to enable a faster start for production. We have approved two qadrivalent vaccines that have the benefit of having two influenza A strains and two influenza B strains instead of just one influenza B strain. And we also … approved the first recombinant influenza vaccine."
Hamburg suggested that the increasing demand for the flu vaccine may help support the additional manufacturers and vaccine types that will be coming to market.
Reports: State legislation targets biosimilar substitution
NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.
In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.
"State legislation concerning the substitution of an interchangeable biosimilar product for the brand-name reference product counterpart has already started cropping up, and 2013 may be the year when legislation takes off and is enacted," Karst wrote, naming Illinois and Virginia as two examples of such states.
In Illinois, a bill that didn’t pass last year but may be introduced this year would allow a prescribing physician to prohibit dispensing a biosimilar and would require the pharmacist to notify the prescriber while both would have to keep a written record of the biosimilar substitution for at least five years. The Virginia legislation, which Karst described as "moving along," would require a pharmacist dispensing a biosimilar in place of a branded biologic to inform the patient and the physician within five days of dispensing.
Alcon launches Ilevro
NEW YORK — Eye care company Alcon has launched a treatment for pain and inflammation resulting from cataract surgery, the company said Monday.
The company said Ilevro (nepafenac) ophthalmic suspension was a nonsteroidal anti-inflammatory drug and once-daily treatment for cataract surgery patients.
"We are committed to developing products that continue to improve patient care," Alcon VP and general manager for U.S. pharmaceuticals Gary Menichini said. "This launch represents the dedication of the [research and development] team to engineer and efficacious, innovative formulation with a reduced dosing regimen."