Federal court rules against Endo in painkiller case
CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.
The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.
Endo launched a reformulated version of Opana ER designed to be crush-resistant in March 2012, but the court’s ruling allows a generic, nontamper-resistant version to be launched on Jan. 2, 2013. The court ruled that the FDA had not unduly delayed making a determination, which it plans to do by May 2013.
"We are extremely disappointed by today’s decision," Endo president and CEO Dave Holveck said. "Despite the fact that the generic product will not be therapeutically equivalent to the crush-resistant formulation, the launch of a generic noncrush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone. We are hopeful that the FDA will ultimately make the right decision before May in light of the surveillance data supporting that the original formulation of Opana ER was discontinued for reasons of safety."
Advocacy group says proposed compounding regulations would endanger public health
WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public’s health and safety at risk.
In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency’s authority in congressional testimony last month and offering a plan that would effectively weaken the agency’s oversight of drug manufacturing."
In testimony before the House Committee on Energy and Commerce last month, Hamburg proposed giving the FDA new power to regulate pharmacy compounding and creating two tiers for compounding: traditional and nontraditional. Traditional would include custom-made medicines for patients with individualized medical needs, while nontraditional compounding would cover compounding that some say effectively amounts to drug manufacturing. Public Citizen said the proposed rules would weaken existing regulations of drug manufacturers and create "substandard requirements" for compounding pharmacies.
The proposed new regulations were made in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass., which has so sickened 620 people and killed 39 in 19 states, according to the Centers for Disease Control and Prevention.
Watson donates medicines to help Hurricane Sandy relief efforts
STAMFORD, Conn. — Actavis has donated $200,000 worth of medicines to help people affected by Hurricane Sandy, a charity organization said Thursday.
AmeriCares announced that it donated the antibiotics, pediatric medicines and other drugs to healthcare providers helping affected families in New York and New Jersey within days of the storm. Actavis was acquired earlier this year by Watson Pharmaceuticals.
"Actavis responded swiftly and generously to meet the medical needs of storm victims," AmeriCares VP corporate relations Geoff Kneisel said. "The company’s donations were an amazing help and were immediately delivered to healthcare providers and first responders in the most devastated areas."