Posted on Apr 02, 2009 | Comments 0
The Food and Drug Administration are trying to cut down on the sale of drugs that have not been approved.
In America, roughly two percent of prescriptions annually are filled with medicine that has yet to be passed suitable.
Nine companies including Covidien Ltd and Glenmark Pharmaceuticals have been warned by the regulators to stop making these drugs giving them sixty days and ninety days to stop shipping them. This will force the various manufacturers to either get the right approval or simply stop what they are doing.
The medicines involved are fourteen narcotic pain relievers and the FDA have made it clear that there is a sufficient number of this type of drug already in production and that there is no justification for their use.
A spokesperson for Coviden Ltd, Steve Littlejohn, explained that their unapproved drug, which is a generic solution of morphine, is not an important part of their company strategy. He insists that they will comply with the order from the FDA and if necessary seek approval for their product.
Another company, Boehringer Ingelheim has already applied for the right status for their hydromorphone hydrochloride 4ml strength tablets. The tablets with a double strength have already been accepted by the FDA and a two milligram version is no longer made by them.
With no shortage in the market place the FDA are determined to crack down on the companies. Many of the latter refused to comment on the regulator’s new initiative. Hopefully they will comply otherwise they will face the rigors of the law.
Posted in: General Health