Generic antidepressant draws complaints.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. said Oct. 25 it is investigating complaints about a generic version of the antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. drug Wellbutrin XL after users reported having headaches, anxiety and other ailments, "The International Herald Tribune International Herald Tribune
Daily newspaper published in Paris. It has long been the staple source of English-language news for American expatriates, tourists, and businesspeople in Europe. " reported.
FDA spokesperson Sandy Walsh told Dow Jones Newswires Dow Jones Newswires is the real-time financial news organization owned by Dow Jones. Founded in 1882, its primary competitors are Bloomberg L.P. and Reuters. The company reports more than 420,000 subscribers -- including brokers, traders, analysts and fund managers -- as of July the agency is also reviewing the scientific formulation of the drug, called Budeprion XL, after a consumer product testing group published results that showed key differences from the original drug.
The tests, conducted by ConsumerLab.com, came after Budeprion XL users earlier this year began complaining that the drug caused severe headaches, digestive problems, anxiety, tremors, and insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. . Another Web site, peoplespharmacy.com, reported that more than 250 people had complained about the drug.
Budeprion XL is made by U.S.-based Impax Laboratories and sold by Israeli firm Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in .
FDA said it could not provide data to support ConsumerLab's findings. "FDA cannot offer any examples where generics have been shown to not perform as expected. FDA has many years of experience in the review of generic drugs and has great confidence in the quality and equivalence of generic drug products," the agency said.
In 2005, Canadian firm Biovial petitioned FDA to require rigorous testing on generic versions of Wellbutrin XL before being approved. While some saw it as a delay tactic, the company said it was to protect patients from serious risks, such as seizures.
FDA approved the first generic versions of Wellbutrin XL in 2006.