Viracept back in the European market
The protease inhibitor Viracept (nelfinavir) is available again in Europe. On 19 Oct 2007, European regulatory authorities reinstated this anti-HIV drug’s market authorisation in the EU [1].
Nelfinavir was first introduced in 1999 and Roche is responsible for supplying the drug in Europe. Last summer, several batches of Viracept were found to have higher-than-normal ethyl mesylate sulphonate (EMS) content. EMS is a known mutagen and teratogen.
There was a wide-spread recall of the product and it was taken off the European market upon the recommendation of European Medicines Agency (EMEA) [2].
Roche immediately took the appropriate steps to correct the manufacturing problems which apparently satisfied the European regulatory authorities, leading to its reinstatement.
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