HHS to open FDA offices in China
WASHINGTON The Department of Health and Human Services will officially open regional offices of the Food and Drug Administration in China, HHS announced Tuesday.
The offices, which will be in Beijing, Shanghai and Guangzhou, are part of an ongoing strategy to improve import safeguards to meet the changing demands of a global economy, the department said. HHS secretary Mike Leavitt and FDA commissioner Andrew von Eschenbach will travel to the three cities and meet with manufacturers and Chinese government officials to discuss policy and governance reforms for improving the safety of food and drugs.
They will also mark the opening of the offices and introduce officials who will work there.
“A permanent FDA presence in China will help us address the challenges presented by globalization,” von Eschenbach said in a statement. “We look forward to working with the Chinese government and manufacturers to ensure that FDA standards for safety and manufacturing quality are met before products ship to the United States.”
The FDA is also setting up offices in India, Latin America, the Middle East and Europe. The Beijing office will be on the grounds of the United States Embassy; the Guangzhou office will be at the U.S. Consulate General; and the Shanghai office will be in the Shanghai Centre, a business complex that is also home to other U.S. government offices.
FDA grants conditional approval to generic version of Wyeth’s Effexor
PITTSBURGH The Food and Drug Administration has given tentative approval to a generic version of Wyeth Pharmaceutical’s Effexor XR, an antidepressant.
Mylan announced the FDA decision Monday for its version of the drug, known generically as venlafaxine hydrochloride. Mylan plans to sell the extended-release capsules in 37.5 mg, 75 mg and 150 mg formulations.
The branded version of the drug had sales of $3 billion during the 12 months ending Sept. 30, according to IMS Health.
Interpol seizes more than $6 million in counterfeit prescription drugs in Asia
NEW YORK More than $6 million in counterfeit drugs were seized in an international Interpol sting as part of an investigation lasting five months.
The bust, called Operation Storm, netted $6.65 million in counterfeits of drugs for malaria, HIV and tuberculosis in Singapore, Myanmar, Vietnam, Thailand, Laos, Cambodia and China.
The international law-enforcement agency arrested 27 people in the sting.