Forest, Daiichi Sankyo sign agreement for Azor
NEW YORK Forest Laboratories and Daiichi Sankyo have signed a co-promotional agreement for Daiichi Sankyo’s new antihypertension drug Azor. Azor is a combination of the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.
Under the agreement, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive a payment based upon product sales. The agreement is for three years, after which, Daiichi Sankyo will make residual payments to Forest.
The drug is still under review by the Food and Drug Administration with a decision expected by late September. Hypertension affects roughly 72 million people in the U.S., with about 65 percent of those diagnosed having trouble keeping it under control.
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.