Ranbaxy sues FDA to protect its exclusive for generic Nexium

Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's ($AZN) blockbuster Nexium and Roche's ($RHHBY) Valcyte. The suit is trying to stop the FDA from approving any other versions of the drugs until it has been able to realize its 180-day exclusives for the drugs, Reuters reports. The FDA this month canceled Ranbaxy's approvals, saying they were made in error because the plants where it intended to produce the drugs were out of FDA compliance when the approvals were granted. It has already approved generics of Valcyte from Endo Health Solutions ($ENDP) and Dr Reddy's Laboratories. The agency has refused to say whether it will allow any other company to produce a generic of the popular Nexium, which went off patent 6 months ago. Story | More

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