Teva receives final FDA approval for generic Famvir, but will delay marketing until patent hearing
JERUSALEM Teva Pharmaceuticals has been granted final approval on its application to market famciclovir, the generic version of Novartis’ Famvir in the 125, 250 and 500mgs.
Now with the approval from the Food and Drug Administration, Teva is also awarded a 180-day period of market exclusivity. But the company will hold off marketing the item until at least Sept. 5, 2007.
On that day, a hearing will be held involving a patent infringement suit brought against Teva regarding the famciclovir. The hearing is scheduled to meet at the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. Therefore, both parties have agreed to not launch a generic version of Famvir until after the hearing.
Court rules that FDA labeling trumps state false-advertising laws
WASHINGTON A potentially precedent-setting case against AstraZeneca has been dismissed by a the U.S. Court of Appeals for the Third Circuit, in connection to a class action lawsuit in a lower court that ruled that drug advertising based on Food and Drug Administration-approved drug labeling is exempt from state false-advertising laws.
The drug named in the lawsuit was Nexium, a medication used for treating acid reflux and heartburn. The plaintiffs claimed that the marketing used for Nexium made it look superior to another AstraZeneca proton-pump inhibitor medication, Prilosec.
In his dissenting opinion, Judge Robert Cowen pointed out that the plaintiffs were not questioning Nexium’s labeling, but rather AstraZeneca’s methods of advertising, and that “there is no risk that a successful state law claim, alleging that Nexium advertisements contain false and misleading drug comparisons, would conflict with the FDA’s approval of the statements in the Nexium labeling.”
NACDS bid to ease MedGuide rules gains a key supporter in U.S. Senate
ALEXANDRIA, Va. An appeal from the National Association of Chain Drug Stores to simplify the daunting patient-education prescription drug guidelines now imposed on community pharmacies has won support from a key member of the Senate Appropriations Committee.
Under rules imposed by the Food and Drug Administration in March, 240 prescription products now require Medication Guides, also known as MedGuides, to help patients understand their medications. NACDS has lobbied the Senate committee for a change in the rules, noting that the MedGuides are “difficult to obtain by pharmacists in an efficient manner,” and that requiring them on so many products could overwhelm patients.
U.S. Sen. Jack Reed, D-R.I., a key member of the committee, responded by inserting language to simplify the MedGuide requirements into the official report that accompanies the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill for Fiscal Year 2008.
“The FDA initially intended the program to produce MedGuides for a limited number of prescription products every year,” noted the committee in its report. “This unanticipated volume of Medguides creates significant administrative burdens for pharmacy providers and has the potential to diminish the usefulness of the program by overwhelming patients with multiple pages of written material.”
NACDS president and chief executive officer Steven Anderson praised Reed for having “brought to light flaws in the current MedGuides system. He called the move “an important step toward meaningful reform that will benefit patients, and the ability of community pharmacy to serve patients,” and pledged that NACDS would continue to push for a simpler MedGuide system.