FDA representatives release information about antibiotic telavancin
NEW YORK Reviewers from the Food and Drug Administration said Wednesday that Theravance’s experimental antibiotic telavancin could treat severe skin infections as well as an older antibiotic with which it was compared. But it might also cause health problems.
Nine people using telavancin died, though nine people using an older antibiotic, vancomycin, died as well. The FDA reviewers also said it might hurt the kidneys and potentially cause birth defects, and animals given the drug experienced limb malformations.
“The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections,” the company said in a statement.
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.