FDA yanks Ranbaxy's tentative approval for generic Nexium

At about the same time that AstraZeneca ($AZN) CEO Pascal Soriot was telling investors its earnings had been boosted because no generic of blockbuster Nexium had appeared, Ranbaxy Laboratories was announcing bad news on that front for itself. The Indian drugmaker said in a statement that the FDA had withdrawn its tentative approval for the drug. Ranbaxy said it also lost tentative approval and approval for the 180-day exclusive rights to a generic of Roche's ($RHHBY) antiviral Valcyte. Both were withdrawn because of Ranbaxy's manufacturing problems at the plants where they were to be made, it said in a statement. Valcyte went off patent last year. Nexium, one of AstraZeneca's best-selling drugs, went off patent in May. Nexium brought in $2.8 billion so far this year for AstraZeneca, almost $1 billion of that during the third quarter. Soriot said that the company is now planning for a Nexium generic to show up in 2015 but was unable to explain just exactly what Ranbaxy's announcement meant for a generic launch. Story | More

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