Conn. attorney general sues FDA over OxyContin warnings
HARTFORD, Conn. Connecticut Attorney General Richard Blumenthal has filed a lawsuit against the Food and Drug Administration in relation to his attempt to get the agency to add stronger warnings for the Purdue Pharma pain killer OxyContin.
Blumenthal said that continued inaction by the FDA on OxyContin warnings and other matters could be devastating because, as the U.S. Department of Justice has confirmed, abuse of prescription drugs such as OxyContin has become the greatest drug threat in the Northeast region.
Blumenthal filed a citizen’s petition in January 2004 as a result of his 2003 investigation into Purdue Pharma. This lawsuit asks for the court to compel the FDA to act on the petition.
In 2004, Blumenthal petitioned the FDA to:
- Strengthen OxyContin’s black box warning to warning to expressly reinforce the FDA approved dosing regimen and to add specific information regarding the potential dangers associated with an off-label dosing schedule.
- Issue a “Dear Healthcare Professional” letter to inform physicians of controlled substances about the potential risks of prescribing OxyContin at dosing intervals that are shorter than the FDA-approved 12-hour dosing schedule.
Arcadia funds DailyMed with $5 million debt facility
INDIANPOLIS Arcadia Resources, a provider of consumer health services doing business under the trade name of Arcadia HealthCare, has obtained a new $5 million debt facility to fund the growth of DailyMed and its related pharmacy fulfillment strategy.
DailyMed, which launched April 2006, is a retail drug packaging solution that pre-sorts multiple prescriptions, OTC medications and vitamins into easy-to-use single-dose packets.
“The financing will provide Arcadia with the cash to fund DailyMed and our related pharmacy fulfillment strategy and the working capital needs associated with the pharmacy business growth anticipated during our fiscal year beginning April 1, 2008,” stated Marvin Richardson, president and chief executive officer. “This deal represents an important first step towards executing our fiscal 2009 growth strategy and is significant in that the majority of debt will be used to grow our DailyMed business rather than meet core operating cash obligations.”
The facility matures on Oct. 31, 2009, bears interest at an annual rate of 10 percent and is secured by certain company assets.
FDA approves Sun’s generic Tessalon
WASHINGTON Sun has received FDA approval for a generic version of Forest Laboratories’ Tessalon capsules, a treatment for coughs due to the common cold, pneumonia and other lung infections.
The company, a week ago, also announced it had received FDA approval for its generic version of Pfizer’s Cerebyx (fosphenytoin sodium), an injectable anticonvulsant that has annual U.S. sales of approximately $15 million.
Brand and generic Tessalon (benzonatate) have annual U.S. sales of approximately $40 million, according to Sun.