Genzyme announces expedited FDA approval of Pompe disease treatment
BOSTON Drug maker Genzyme said Monday that the Food and Drug Administration would accelerate approval of Myozyme, its drug for treating Pompe disease.
Prior to approval, Genzyme and the FDA first need to agree on the design of a post-approval verification study, and the FDA must finish its review of the drug?s risk evaluation and mitigation strategy, which Genzyme submitted earlier this month. Myozyme is known generically as alglucosidase alfa.
“The ongoing communication with the FDA has been positive, and the agency has done a substantial amount of work in a short time to facilitate approval of this product for patients,” Genzyne senior vice president of global market access Alison Lawton said in a statement.
Pompe disease is a debilitating and life-threatening hereditary disorder that affects about 2,000 people in the United States.
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.