KV’s Ethex to plead guilty to criminal charges
ST. LOUIS The generic drug marketing and distribution division of KV Pharmaceuticals will plead guilty to criminal charges and close shop under a deal between KV and the Department of Justice, KV announced Thursday.
The generic drug maker said Ethex will plead guilty to two felony counts and pay $27.6 million to resolve a criminal investigation of the company that began amid allegations that it failed to file field alerts to inform regulators of manufacturing problems with the drugs dextroamphetamine and propafenone in 2008. The payment includes a fine, $2.3 million in restitution to the federal government and an administrative forfeiture of $1.8 million.
“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward,” KV interim CEO David Van Vliet said in a statement. “Management and the board have been working diligently to address this issue, and we are looking forward to having this matter resolved.”
Ethex recalled a large number of generic drugs in late 2008 and early 2009 due to problems such as possibly oversized tablets and manufacturing deficiencies. In March 2009, the Food and Drug Administration filed an injunction against KV to prevent it from making or distributing adulterated and unapproved drugs and forced it to destroy all the drugs it had recalled, forbidding it from resuming manufacturing until the FDA was satisfied that it had been brought back into compliance with regulations. KV said the current settlement would allow it to continue manufacturing once it had regained compliance with the FDA’s current good manufacturing practices regulations, also known as cGMP.
Kerr Drug honored for MTM services
RALEIGH, N.C. Thousands of patient interventions by Kerr Drug pharmacists have earned the chain recognition from a leading pharmaceutical health provider as the nation’s top provider of pharmacy-based medication therapy management.
It’s the third year in a row Kerr has won the honor, bestowed by Outcomes Pharmaceutical Health Care, a national MTM provider network. In bestowing the award, Outcomes noted that Kerr pharmacists served nearly 10,000 MTM-eligible patients in 2008, saving more than $2 million in estimated costs.
“Over the past year, Kerr Drug has remained a front-runner in the provision of MTM services and has clearly demonstrated the value pharmacists deliver to the health care system,” said Outcomes VP Brand Newland.
Outcomes also named the Kerr store in Moncks Corner, S.C., as the top individual pharmacy for 2008 in its eighth region, an operating area that represents Georgia and South Carolina.
New drug application review for Exenatide extended
INDIANAPOLIS A diabetes drug developed by Amylin, Eli Lilly and Alkermes will be reviewed by the Food and Drug Administration March 12.
The revised action date of Exenatide once weekly is the result of the FDA’s decision to allow five additional days for its review of pending regulatory applications following the agency’s recent five-day weather-related closure.
Exenatide once weekly is an investigational, extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.