The U. S. Food & Drug Administration (FDA) has ordered Teva Pharmaceuticals to pull its generic antidepressant Budeprion XL from the market.
The FDA issued the order after it found that Budeprion XL wasn’t an equivalent of Wellbutrin XL manufactured by GlaxoSmithKline. The FDA’s recent ruling about the Teva’s generic antidepressant is in sharp contrast to its own
2009 ruling when it said that Budeprion XL was an equivalent to Wellbutrin XL.
The reversal followed a five-year dispute that raised questions on the claim that generic drugs work just similar to the more expensive brand name medicines.
Millions of patients in the U. S. switched from GlaxoSmithKline’s Wellbutrin XL to its supposedly cheaper equivalent Budeprion XL, but a great number of them started experiencing problems like headaches and anxiety.
A complainant said, “I've been on Wellbutrin for several years and things were fine and dandy, but once I was switched I started experiencing headaches, anxiety, depression and sleeplessness.”
Many patients who had never been felt suicidal tendencies started reporting suicidal thoughts all of a sudden.
Apart from ordering removal of Budeprion XL from the market, the FDA has called on four other generic drug manufacturers, viz. Activis, Anchen, Watson and Mylan, to conduct tests to determine if the drugs they produce really meet the agency’s standards.
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