Glenmark to withdraw painkiller from US market
02 Apr 2009
Indian drug-maker Glenmark Pharmaceuticals Ltd said on Wednesday that it would stop distributing its morphine sulfate tablets and solutions, complying with a warning from the US Food and Drugs Administration, and added that the impact on its finances would be ''insignificant''.
Late on Tuesday, the FDA warned nine firms, including Glenmark, to stop selling 14 unapproved narcotic pain drugs as part of an ongoing effort to rid the market of drugs without proper clearance. "In compliance with the conditions of the warning letter, Glenmark will cease distribution of their morphine sulfate product line within the timeline indicated by the FDA," Glenmark said in a statement.
The FDA has asked the companies concerned to stop manufacturing the unapproved versions within 60 days and stop shipments within 90 days. Nine companies, including Glenmark, were affected.
Morphine Sulfate is a generic prescription for pain management, which was launched by Glenmark in the US in December 2008. The FDA said these warning letters were part of the FDA's initiative on marketed unapproved drugs announced in June 2006 and said they would continue to take aggressive action against firms that do not have required approval for drugs.
Glenmark said in its defence, ''By nature it didn't require an abbreviated new drug application (ANDA) approval because these drugs were in existence before 1938. It only needed good manufacturing practices (GMP) compliance."
