Merck’s application for Cordaptive accepted by FDA
WHITEHOUSE STATION, N.J. The Food and Drug Administration has accepted the application by Merck & Co. for their drug Cordaptive for standard review.
Cordaptive is a compound of extended-release niacin and laropiprant that can be used alone or with a statin as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol, and elevated triglyceride levels.
The company will try to present phase III data for the drug at the September 2007 Scientific Meeting of the European Society of Cardiology and the November 2007 Scientific Meeting of the American Heart Association.
BlueCross/BlueShield of Oregon introduces new generics program
PORTLAND, Ore. Regence BlueCross BlueShield of Oregon has introduced a new program called Generics First Antidepressant Program, to help battle rising healthcare costs.
The program encourages the use of high-quality antidepressant generic medications. Since the company believes generics can meet the needs of most patients, brand-name drugs will require a prior authorization beginning in September. This though, does not necessarily mean that people already on brand-name medications will need a prior authorization.
Prices could result as follows, a 30-day supply of a generic could be $30 compared to a brand-name drug, which could cost $83. “These generics are a good value for members and are available without prior authorization,” said David Clark, vice president of Medical Services and Pharmacy for Regence.
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.