AmerisourceBergen opens Orlando DC after deal with FDA
VALLEY FORGE, Pa. AmerisourceBergen Corp. announced that on August 25, 2007 the Drug Enforcement Administration reinstated AmerisourceBergen’s license for its Orlando Distribution Center to distribute controlled substances. The distribution center immediately resumed shipment of controlled substances to its customers.
The license was suspended in April 2007 because the DEA alleged that the distribution center had not maintained effective controls against diversion of controlled substances by retail Internet pharmacies. During the suspension, the company was able to provide the products to its customers from another distribution center.
Due to the suspension, AmerisourceBergen implemented an enhanced and more sophisticated order-monitoring program in all of its distribution centers starting July 1, 2007, The company has since passed several DEA inspections of the new program. AmerisourceBergen said that it expects the new order monitoring program to quickly become the industry standard, as it requires more rapid identification and daily reporting of orders that may indicate diversion of controlled substances, and, in some instances, may even require halting a shipment of orders to further investigate. The monitoring program also requires a more rigorous examination process before the delivery of controlled substances to newly signed customers.
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.
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.