Glaxo Corrects Defects in Two Drugs
Drug company GlaxoSmithKline has signed a consent decree with the U.S. Food and Drug Administration that it has corrected the causes of manufacturing defects in the antidepressant Paxil CR and the diabetes drug Avandamet.
The agreement means that the two drugs could be back on the market by the middle of this year, months earlier than expected, The New York Times reported.
In February, Glaxo recalled some batches of Paxil that were splitting apart. In March, the FDA shut the Cidra, Puerto Rico, plant that makes Paxil and Avandamet and also seized inventories of the two drugs stored in Knoxville, Tenn.
The defective Paxil CR tablets that split apart had one half a tablet with no medication and another half with no buffering product. Some Avandamet pills contained inconsistent doses of medicine, the Times reported.
The company also agreed to put an independent observer at the factory in Cidra.
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