US FDA strikes again

US FDA has issued a warning letter to Indian drug maker Glenmark Pharma for its pain management drug morphine sulfate. In its letter to the pharma major, US FDA has asked Glenmark to stop manufacturing Morphine Sulfate tablets and solutions. Morphine Sulfate is a generic prescription for pain management.US FDA said that the manufacturer have 60 days to stop manufacturing these products while the distributors have 90 days to stop shipping existing products.

It said that the warning letters is a part of FDA’s initiatives announced in June, 2006. And the authority will continue to take aggressive action against firms that do not have required approval for drugs.

In response to the US FDA letter, Glenmark said that by nature, it didn’t require an ANDA approval because these drugs were in existence before 1938. It only needed GMP compliance.

Morphine Sulfate was launched by Glenmark Pharma in the US in December, 2008 and its financial impact on the company is insignificant.

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