US FDA gives Glenmark 60 days to stop pain drug production
The US Food and Drug Adminstration (FDA) has issues a warning letter to Indian drug maker Glenmark Pharma to stop manufacturing Morphine Sulfate tablets and solutions. Morphine Sulfate is generic prescription for pain management, which was launched by Glenmark in the US in December, 2008. The financial impact of this letter on the company, however, would be insignificant.
The US FDA has given Glenmrk Pharma 60 days to stop manufacturing these products and given distributors 90 days to stop shipping existing products.
The US 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 in its defense said, “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.