GlaxoSmithKline signed a consent decree with the Food and Drug Administration to correct manufacturing deficiencies at a Puerto Rico plant the FDA says could have resulted in the production of drugs harmful to consumers. The drugmaker will post a penal bond of $650 million to ensure that the drugmaker successfully reconditions or destroys drugs that were seized in March and pay costs to the government.
The FDA's last inspection found Paxil CR tablets, which treat depression and anxiety disorders, could split apart, officials said. The concern is that the deficiency could cause patients to receive a portion of the pill that does not contain any active ingredient or the intended controlled-release effect. Also, some Avandamet tablets for Type II diabetes did not contain an accurate dose of one of its active ingredients, rosiglitazone.
Glaxo said in a news release that the company is "fully committed to working cooperatively with the FDA to address any such issues in a timely fashion." The company, which confirmed its earnings guidance, expecting growth of 10% to 14%, also said it believes it has identified the source of the manufacturing issues. The decree will take effect after the U.S. District Court in North Carolina has approved it.